N/A 4301CRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885403057038), received between Feb 8, 2021 and Dec 3, 2024 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 20, 2022Open, Classified

   Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

   Z-0792-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY CUSTOMER THAT WHEN PHYSICIAN RECAPPING NEEDLE, THE NEEDLE WENT THROUGH CAP AND STUCK PHYSICIAN. RCC RECEIVED A COMPLAINT VIA EMAIL. WHEN PHYSICIAN RECAPPING NEEDLE, THE NEEDLE WENT THROUGH CAP AND STUCK PHYSICIAN. PHYSICIAN REPORTED CONCERNED THAT THE NEEDLE SHOULDN'T PIERCE THE CAP AS EASILY AS IT DID, HE TESTED ANOTHER TYPE OF NEEDLE AND TOOK EXTREME PRESSURE TO PIERCE. THERE WERE NO CONCERNS WITH PHYSICIAN SKILL AND RECAPPING SINAL NEEDLES WAS REPORTED AS A COMMON PRACTICE. THE PRODUCT WAS NOT SAVED. CUSTOMER RESPONSE ON (B)(6) 2024 FOR FU 2. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 14-07-2024. 2. BATCH NUMBER [1487945] WAS NOT FOUND, CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT NUMBER 0001487945. 3. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? IT IS OUR UNDERSTANDING THAT THE EVENT OCCURRED AFTER USE WHEN PHYSICIAN RECAPPED NEEDLE. 4. DID THE NEEDLE STICK INJURY OCCUR WITH A CONTAMINATED OR CLEAN NEEDLE? PER REVIEW OF MEDICAL RECORD, STICK INJURY OCCURRED WITH A CONTAMINATED NEEDLE. 5. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE T

  Patient problems: Needle Stick/Puncture

  MAUDE report 20834414 ↗
• MalfunctionSep 27, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE PERFORMED 2 LUMBAR PUNCTURES IN THE PAST 24 HOURS AND HAVE NOTICED THAT THE NEW NEEDLE (WITH THE BLACK TIP) IS EXTREMELY DULL AND TAKES A LOT OF MUSCLE AND PRESSURE TO BE ABLE TO POKE THROUGH THE SKIN. IT ALMOST CANNOT GO THROUGH THE SKIN AT ALL. THIS SEEMS UNSAFE TO HAVE TO APPLY THAT MUCH PRESSURE, AND CUSTOMER NOTED THAT THE NEEDLE WAS BENT FROM THE AMOUNT OF FORCE NEEDED TO OBTAIN THE PUNCTURE. VERBATIM: I HAVE PERFORMED 2 LUMBAR PUNCTURES IN THE PAST 24 HOURS AND HAVE NOTICED THAT THE NEW NEEDLE (WITH THE BLACK TIP) IS EXTREMELY DULL AND TAKES A LOT OF MUSCLE AND PRESSURE TO BE ABLE TO POKE THROUGH THE SKIN. IT ALMOST CANNOT GO THROUGH THE SKIN AT ALL. THIS SEEMS UNSAFE TO HAVE TO APPLY THAT MUCH PRESSURE, AND I NOTED THAT THE NEEDLE WAS BENT FROM THE AMOUNT OF FORCE NEEDED TO OBTAIN THE PUNCTURE.

  Patient problems: Insufficient Information

  MAUDE report 17826006 ↗
• InjuryFeb 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SPINAL NEEDLE WAS LEAKING. IT WAS ALSO REPORTED THAT THE LIDOCAINE AND CHLRAPREP SWABSTICK WERE MISSING. VERBATIM: SRG-LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP. THE SPINAL NEEDLE IN ADULT LUMBAR PUNCTURE TRAY WAS DEFECTIVE AND DIDN'T BREAK BUT WAS LEAKING BETWEEN THE PLASTIC HUB AND THE NEEDLE SHAFT DURING A LUMBAR PUNCTURE FOR A BACLOFEN TRIAL WHERE A MEDICATION NEEDED TO BE ADMINISTERED VIA THE SPINAL NEEDLE INTRATHECALLY. THEREFORE, PROVIDER NEEDED TO REMOVE THAT SPINAL NEEDLE AND INSERT A SECOND SPINAL NEEDLE (NOT IN KIT) TO ASSURE ADMINISTRATION OF THE FULL DOSE OF MEDICATION. SO, PATIENT ENDED UP NEEDING 2 LUMBAR PUNCTURES DUE TO DEFECTIVE SPINAL NEEDLE IN KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536405 ↗
• InjuryDec 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE IS A LEAK IN THE MANOMETER. THE PAST 3-4 LUMBAR TRAYS WE¿VE UTILIZED HAVE HAD A LEAK IN THE MANOMETER, THIS INSTRUMENT MEASURES INTERCRANIAL PRESSURE AND THE LEAK IMPACTS THE ACCURACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060762 ↗
• InjuryNov 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CLINICIANS HAVE REPORTED THERE'S LEAKAGE WHICH PREVENTS THEM FROM OBTAINING AN ACCURATE OPENING PRESSURE. DEFECT REPORTED AT THE BASE OF THE MANOMETER WHERE THE STOP COCK IS CONNECTED, CLINICIANS HAVE REPORTED THERE'S LEAKAGE WHICH PREVENTS THEM FROM OBTAINING AN ACCURATE OPENING PRESSURE. IT'S AFFECTING 2 LOT NUMBERS BUT NOT CONSISTENTLY. I DO NOT BELIEVE THIS CAN ISSUE IS ATTRIBUTED TO USER ERROR, THE MANOMETER HAS BEEN SECURELY PLACED IN THE STOP-COCK. WERE THERE ANY ADVERSE EVENTS AS A RESULT OF THE REPORTED FAILURE? UNKNOWN BUT NOT REPORTED. IS A SAMPLE AVAILABLE TO RETURN FOR EVALUATION? NO, IT WAS DISCARDED ONSITE AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860911 ↗
• InjuryNov 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MANOMETER STILL HAVING LEAKING ISSUES. VERBATIM: THE SEPARATE MANOMETERS ARE NOW LEAKING ALSO SO WE NEED A DIFFERENT ALTERNATIVE. RIGHT NOW I HAVE A PATIENT THAT WE NEED TO BRING BACK FOR ANOTHER LUMBAR PUNCTURE FOR OPENING PRESSURE TO DETERMINE IF SHE WILL NEED SURGERY OR NOT BECAUSE DR. (B)(6) IS NOT COMPETENT IN THE READINGS. I HAVE 1 KIT AND 3 MANOMETER IN MY OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857277 ↗
• InjuryNov 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED LEAKAGE. VERBATIM: PER CUSTOMER'S RESPONSE VIA E-MAIL 10/26/2021. WHAT IS THE DATE YOU INFORMED BD ABOUT THIS EVENT, IS IT (B)(6) 2021? THE ATTACHED DOCUMENT YOU SUBMITTED SAYS 10/04/2120? EVENT DATE (B)(6) 21- (B)(6) 21 HOWEVER NOT SUBMITTED TIL (B)(6) 21. ARE THE TWO DATES OF OCCURRENCE AS STATED ON THE ATTACHED DOCUMENT: (B)(6) 2021-(B)(6) 2021? YES. HAVE YOU REPORTED THIS SAME COMPLAINT IN THE PAST, AND IF SO, WHEN? SAME REPEATED ISSUE HOWEVER THESE ARE ADDITIONAL LOT NUMBERS (EXAMPLE PR # 3759648) WAS THERE A NEED TO REPEAT THE PROCEDURE? NO HOWEVER INACCURATE OPENING AND CLOSING PRESSURE FOR PATIENT WITH IIH. WAS THE SPECIMEN CONTAMINATED? NO. WHAT WAS DONE TO RESOLVE THE ISSUE? TIGHTENED ALL CONNECTIONS WITH CONTINUED LEAKING, PUSHED IN WHITE STOPCOCK WITH CONTINUED LEAKING. OPENED A SECOND TRAY WITH NEW MANOMETER AND STOPCOCK WITH CONTINUED LEAKING DESPITE REPEATING ALL OF THE ABOVE INTERVENTIONS. WAS THERE ANY CRACKS OR BREAKAGE NOTICED AT THE CONNECTION POINT? NO IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? YES ATTACHED. IF SAMPLE IS AVAILABLE, PLEASE PROVIDE ADDRESS RETURNING FROM. THE CLINICIAN WAS NOT ABLE TO OBTAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745241 ↗
• InjuryNov 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED LEAKAGE VERBATIM: PER CUSTOMER'S RESPONSE VIA E-MAIL 10/26/2021: WHAT IS THE DATE YOU INFORMED BD ABOUT THIS EVENT, IS IT (B)(6) 2021? THE ATTACHED DOCUMENT YOU SUBMITTED SAYS (B)(6) 2020? EVENT DATE: (B)(6) 2021- (B)(6) 2021 HOWEVER NOT SUBMITED TIL (B)(6) 2021. ARE THE TWO DATES OF OCCURRENCE AS STATED ON THE ATTACHED DOCUMENT: (B)(6) 2021-(B)(6) 2021? YES. HAVE YOU REPORTED THIS SAME COMPLAINT IN THE PAST, AND IF SO, WHEN? SAME REPEATED ISSUE HOWEVER THESE ARE ADDITIONAL LOT NUMBERS (EXAMPLE (B)(4)). WAS THERE A NEED TO REPEAT THE PROCEDURE? NO. HOWEVER, INACCURATE OPENING AND CLOSING PRESSURE FOR PATIENT WITH IIH. WAS THE SPECIMEN CONTAMINATED? NO. WHAT WAS DONE TO RESOLVE THE ISSUE? TIGHTENED ALL CONNECTIONS WITH CONTINUED LEAKING, PUSHED IN WHITE STOPCOCK WITH CONTINUED LEAKING. OPENED A SECOND TRAY WITH NEW MANOMETER AND STOPCOCK WITH CONTINUED LEAKING DESPITE REPEATING ALL OF THE ABOVE INTERVENTIONS. WAS THERE ANY CRACKS OR BREAKAGE NOTICED AT THE CONNECTION POINT? NO. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? YES ATTACHED. IF SAMPLE IS AVAILABLE, PLEASE PROVIDE ADDRESS RETURNING FROM. NA. THE CLINICIAN WAS NOT ABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745237 ↗
• InjuryOct 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE ON 2 OUT OF 3 LUMBAR PUNCTURES, AND WERE NOT ABLE TO OBTAIN ACCURATE PRESSURES. VERBATIM: TODAY, THERE WAS LEAKAGE ON 2 OF THE 3 LUMBAR PUNCTURES AND THEREFORE WE COULD NOT OBTAIN ACCURATE OPENING OR CLOSING PRESSURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674341 ↗
• InjuryOct 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  MATERIAL NO.: 4301C BATCH NO.: 0001422197, 0001429130, 0001426189. IT WAS REPORTED THAT 3 OUT OF 4 TRAYS LEAKED. WAS THERE A NEED TO REPEAT THE PROCEDURE? NO. WAS THE SPECIMEN CONTAMINATED? NO. WHAT WAS DONE TO RESOLVE THE ISSUE? TIGHTENED ALL CONNECTIONS WITH CONTINUED LEAKING, PUSHED IN WHITE STOPCOCK WITH CONTINUED LEAKING. OPENED A SECOND TRAY WITH NEW MANOMETER AND STOPCOCK WITH CONTINUED LEAKING DESPITE REPEATING ALL OF THE ABOVE INTERVENTIONS. WAS THERE ANY CRACKS OR BREAKAGE NOTICED AT THE CONNECTION POINT? NONE VISIBLE IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? ATTACHED. IF SAMPLE IS AVAILABLE, PLEASE PROVIDE ADDRESS RETURNING FROM. NA. ONE POINT FOR CLARIFICATION, ALTHOUGH THE PROCEDURE WAS NOT REPEATED, THE REQUESTED CLINICAL INFORMATION (OPENING AND CLOSING PRESSURES) COULD NOT BE PROVIDED TO THE CLINICIAN BECAUSE OF THE LEAKAGE. VERBATIM: IN THE CAT 4301C ADULT LUMBAR PUNCTURE TRAY MADE BY CAREFUSION, THE NEURORADIOLOGY TEAM HAS CONSISTENTLY BEEN FINDING THE STOPCOCKS LEAKING CSF DURING LUMBAR PUNCTURES, PREVENTING AN ACCURATE MANOMETER READING. AT TIMES THE STOP COCK LEAKS AT THE BOTTOM. AT TIMES TO STOP COCK LEAKS WHERE IT CON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12655964 ↗
• InjurySep 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT STOPCOCKS ARE LEAKING PREVENTING AN ACCURATE MANOMETER READING. VERBATIM: AT MUSC WE USE THE CAT 4301C ADULT LUMBAR PUNCTURE TRAY MADE BY CAREFUSION. WE HAVE CONSISTENTLY BEEN FINDING THE STOPCOCKS LEAKING PREVENTING AN ACCURATE MANOMETER READING. AT TIMES THE STOP COCK LEAKS AT THE BOTTOM. AT TIMES TO STOP COCK LEAKS WHERE IT CONNECTS WITH THE MANOMETER DESPITE TIGHT CONNECTIONS. THIS OCCURS IN APPROXIMATELY 3 OUT OF 4 TRAYS. I SUSPECT A DEFECT IN THE STOPCOCKS AND/OR MANOMETER WHERE IT CONNECTS TO THE STOPCOCK. THIS OCCURRED TODAY WITH BOTH LUMBAR PUNCTURES I DID. LOT NUMBER 0001415809, EXP. DATE 2022-04-30 AND LOT NUMBER 0001422604, EXP. DATE 2022-06-30. THIS IS MAKING INACCURATE MANOMETERS READING WHICH IS INTERFERING WITH APPROPRIATE CARE. I SUSPECT YOU MAY NEED TO RECALL THIS PRODUCTS AS IT CONTINUES TO OCCUR. PLEASE DIRECT ME HOW TO RECTIFY THIS SITUATION. WAS THERE A NEED TO REPEAT THE PROCEDURE? NEITHER PROCEDURE WAS REPEATED. WAS THE SPECIMEN CONTAMINATED? THE SPECIMEN WAS NOT CONTAMINATED AS WE USE STERILE TECHNIQUE FOR THE PROCEDURE AND ALL EQUIPMENT REMAINED STERILE. WHAT WAS DONE TO RESOLVE THE ISSUE? ALL CONNECTIONS WERE TIGHTENED, EXTENSION TUBI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556236 ↗
• InjurySep 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT STOPCOCKS ARE LEAKING PREVENTING AN ACCURATE MANOMETER READING. VERBATIM: AT MUSC WE USE THE CAT 4301C ADULT LUMBAR PUNCTURE TRAY MADE BY CAREFUSION. WE HAVE CONSISTENTLY BEEN FINDING THE STOPCOCKS LEAKING PREVENTING AN ACCURATE MANOMETER READING. AT TIMES THE STOP COCK LEAKS AT THE BOTTOM. AT TIMES TO STOP COCK LEAKS WHERE IT CONNECTS WITH THE MANOMETER DESPITE TIGHT CONNECTIONS. THIS OCCURS IN APPROXIMATELY 3 OUT OF 4 TRAYS. I SUSPECT A DEFECT IN THE STOPCOCKS AND/OR MANOMETER WHERE IT CONNECTS TO THE STOPCOCK. THIS OCCURRED TODAY WITH BOTH LUMBAR PUNCTURES I DID. LOT NUMBER 0001415809, EXP. DATE 2022-04-30 AND LOT NUMBER 0001422604, EXP. DATE 2022-06-30. THIS IS MAKING INACCURATE MANOMETERS READING WHICH IS INTERFERING WITH APPROPRIATE CARE. I SUSPECT YOU MAY NEED TO RECALL THIS PRODUCTS AS IT CONTINUES TO OCCUR. PLEASE DIRECT ME HOW TO RECTIFY THIS SITUATION. WAS THERE A NEED TO REPEAT THE PROCEDURE? NEITHER PROCEDURE WAS REPEATED. WAS THE SPECIMEN CONTAMINATED? THE SPECIMEN WAS NOT CONTAMINATED AS WE USE STERILE TECHNIQUE FOR THE PROCEDURE AND ALL EQUIPMENT REMAINED STERILE. WHAT WAS DONE TO RESOLVE THE ISSUE? ALL CONNECTIONS WERE TIGHTENED, EXTENSION TUBI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556228 ↗
• InjurySep 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THERE IS NOT A GOOD SEAL BETWEEN THE MANOMETER AND STOP-COCK CAUSING LEAKAGE OF SPINAL FLUID. PROVIDED: WE NEED TO LOG A Q-PULSE FOR THE LUMBAR PUNCTURE TRAYS THAT ARE NOT PROVIDING A GOOD SEAL WITH THE MANOMETER AND STOP-COCK DURING A PROCEDURE. SO FAR, EVERY LOT NUMBER HAS BEEN A PROBLEM. I HAVE AT LEAST 10 KITS THAT CANNOT BE USED. ALSO WE DO NOT WANT ANYMORE FROM THE CSC. THIS IS JUST A NEW LOT NUMBER IN A SERIES OF LOT NUMBERS WITH THE SAME PROBLEM. I NEED A NEW PRODUCT FROM A DIFFERENT VENDOR/MANUFACTURER. THE MANOMETER DOES NOT SEAL WELL INTO THE STOP COCK AND THEN SPINAL FLUID IS LEAKING CAUSING AN ERRONEOUS READING FOR FLUID PRESSURE. (B)(6) HOSPITAL (B)(6) WILL HAVE TO STOP PERFORMING THESE PROCEDURES IF WE CANNOT GET SOME RESOLUTION TO THIS PROBLEM. THE BELOW LOT HAS BEEN IDENTIFIED AS NOT SEALING WHEN USING THE STOP-COCK INSIDE THE KIT. THIS RESULTS IN A LOSS OF PRESSURE AND FLUID LEAKING EVERYWHERE. IT HAS BEEN REPORTED TO THE VENDOR AS A PRODUCT FAILURE. IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THERE IS LEAKAGE OF SPINAL FLUID AT THE CONNECTION POINT AT THE STOPCOCK WHICH DOES NOT SEAL PROPERLY. BOTH OF THESE LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441073 ↗
• InjurySep 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THERE IS NOT A GOOD SEAL BETWEEN THE MANOMETER AND STOP-COCK CAUSING LEAKAGE OF SPINAL FLUID. PROVIDED: WE NEED TO LOG A Q-PULSE FOR THE LUMBAR PUNCTURE TRAYS THAT ARE NOT PROVIDING A GOOD SEAL WITH THE MANOMETER AND STOP-COCK DURING A PROCEDURE. SO FAR, EVERY LOT NUMBER HAS BEEN A PROBLEM. I HAVE AT LEAST 10 KITS THAT CANNOT BE USED. ALSO WE DO NOT WANT ANYMORE FROM THE CSC. THIS IS JUST A NEW LOT NUMBER IN A SERIES OF LOT NUMBERS WITH THE SAME PROBLEM. I NEED A NEW PRODUCT FROM A DIFFERENT VENDOR/MANUFACTURER. THE MANOMETER DOES NOT SEAL WELL INTO THE STOP COCK AND THEN SPINAL FLUID IS LEAKING CAUSING AN ERRONEOUS READING FOR FLUID PRESSURE. MERCY HOSPITAL OKC WILL HAVE TO STOP PERFORMING THESE PROCEDURES IF WE CANNOT GET SOME RESOLUTION TO THIS PROBLEM. THE BELOW LOT HAS BEEN IDENTIFIED AS NOT SEALING WHEN USING THE STOP-COCK INSIDE THE KIT. THIS RESULTS IN A LOSS OF PRESSURE AND FLUID LEAKING EVERYWHERE. IT HAS BEEN REPORTED TO THE VENDOR AS A PRODUCT FAILURE. IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THERE IS LEAKAGE OF SPINAL FLUID AT THE CONNECTION POINT AT THE STOPCOCK WHICH DOES NOT SEAL PROPERLY. BOTH OF THESE LOT NUMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441054 ↗
• InjurySep 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE BETWEEN THE MANOMETER AND STOPCOCK. PER COMPLAINT DETAILS RECEIVED: MEMBER RECEIVED INACCURATE OPENING AND CLOSING PRESSURE DURING HER LUMBAR PUNCTURE DUE TO A FAULTY LOT OF MANOMETERS AND OR STOPCOCKS IN OUR LUMBAR PUNCTURE TRAYS. STAFF NOTICED A LEAK OF CSF FLUID BETWEEN THE MANOMETER AND STOPCOCK. A NEW TRAY WAS OPENED AND REPLACE WITH NEW EQUIPMENT, BUT THERE WAS STILL A LEAK. HE THEN PROCEEDED TO EXCHANGE THE MANOMETER FOR A THIRD TIME AND THERE WAS STILL A LEAK. CAREFUSION ADULT LUMBAR PUNCTURE TRAYS CONTAIN FAULTY MANOMETERS AND OR FAULTY STOPCOCKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12409221 ↗
• InjuryAug 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THERE IS LEAKAGE OF SPINAL FLUID AT THE CONNECTION POINT AT THE STOPCOCK WHICH DOES NOT SEAL PROPERLY. PER EMAIL: BOTH OF THESE LOT NUMBERS HAVE BEEN PULLED FROM X-RAY. WHEN THE PRESSURE GAGE IS CONNECTED TO THE TUBING FROM THE SPINAL NEEDLE AND THE SPINAL FLUID BEGINS TO FLOW, IT DRIPS FROM THE CONNECTION POINT AT THE STOPCOCK ONTO THE FLOOR EXPOSING EVERYONE TO SPINAL FLUID. THIS DOES CREATE PATIENT HARM DUE TO LOSS OF PRESSURE FOR AN ACCURATE SPINAL FLUID PRESSURE READING. SO THE PHYSICIANS ARE NOT RECEIVING ACCURATE INFORMATION. THEREFORE THIS MAY AFFECT THE TREATMENT FOR THE PATIENT. WE DO HAVE A TRAY WITH THIS LAST LOT NUMBER. WE CONTINUE TO HAVE ADDITIONAL LOTS WHERE THE TUBE DOES NOT SEAL WHEN PLACED IN THE STOP COCK. LOT# 0001415850 IS HAVING THE SAME PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353740 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  MATERIAL NO.: 4301C; BATCH NO.: 0001417243. IT WAS REPORTED THAT DURING LUMBAR PUNCTURE, A LEAK WAS NOTICED. VERBATIM: THIS R-SBAR IS BEING SUBMITTED AS AN INFORMATIONAL TOOL REGARDING AN UNUSUAL OCCURRENCES: SITUATION :MEMBER RECEIVED INACCURATE OPENING AND CLOSING PRESSURE DURING HER LUMBAR PUNCTURE DUE TO A FAULTY LOT OF MANOMETERS AND OR STOPCOCKS IN OUR LUMBAR PUNCTURE TRAYS. B: BACKGROUND: DURING THE MEMBER'S LUMBAR PUNCTURE WHILE OBTAINING OPENING PRESSURES DR. (B)(6) AND I NOTICED A LEAK OF CSF FLUID BETWEEN THE MANOMETER AND STOPCOCK. I OPENED A NEW TRAY AND DR.(B)(6) EXCHANGED THE OLD STOPCOCK FOR THE NEW ONE, BUT THERE WAS STILL A LEAK. HE THEN PROCEEDED TO EXCHANGE THE MANOMETER AND WE FOUND THERE WAS STILL A LEAK. A: ASSESSMENT: CAREFUSION ADULT LUMBAR PUNCTURE TRAYS CAT. 4301C; LOT NO: 0001417243; CONTAIN FAULTY MANOMETERS AND OR FAULTY STOPCOCKS. R: RECOMMENDATION/REQUEST: PER THE ORDERING NEUROLOGIST THE MEMBER WILL NEED ANOTHER LUMBAR PUNCTURE TO OBTAIN ACCURATE OPENING AND CLOSING PRESSURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310306 ↗
• InjuryFeb 8, 2021Material Twisted/Bent; Material Twisted/Bent

  MATERIAL NO: 4301C BATCH NO: 0001361944. THE FOLLOWING WAS REPORTED VIA EMAIL: PROVIDER INJECTED PATIENT WITH LIDOCAINE DURING A LUMBAR PUNCTURE AND WENT TO RECAP THE NEEDLE AND THE NEEDLE WHEN THROUGH THE CAP AND PUNCTURED HER LEFT INDEX FINGER. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? RECAP THE NEEDLE WITHOUT THE NEEDLE GOING THROUGH THE SAFETY CAP. PER CUSTOMER'S ANSWERS VIA E-MAIL: THE ATTACHED FORM STATED THAT YOU DON¿T HAVE PHYSICAL SAMPLES, WE JUST WANT TO MAKE SURE IF YOU HAVE ANY PHYSICAL SAMPLES THAT YOU COULD RETURN FOR EVALUATION? NO, THE PHOTOS SENT WITH THE INCIDENT IS WHAT WE HAVE. THERE ARE NO OTHER SAMPLES. DID THE PERSON WHO WAS STUCK WITH THE NEED SEEK ANY MEDICAL ATTENTION? YES. WOULD YOU PLEASE BE ABLE TO PROVIDE US WITH PATIENT IDENTIFIERS? NO.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11293136 ↗
• MalfunctionFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MATERIAL NO: 4301C. BATCH NO: 0001361944. THE FOLLOWING WAS REPORTED VIA EMAIL: PROVIDER INJECTED PATIENT WITH LIDOCAINE DURING A LUMBAR PUNCTURE AND WENT TO RECAP THE NEEDLE AND THE NEEDLE WHEN THROUGH THE CAP AND PUNCTURED HER LEFT INDEX FINGER. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? RECAP THE NEEDLE WITHOUT THE NEEDLE GOING THROUGH THE SAFETY CAP. PER CUSTOMER'S ANSWERS VIA E-MAIL: THE ATTACHED FORM STATED THAT YOU DONT HAVE PHYSICAL SAMPLES, WE JUST WANT TO MAKE SURE IF YOU HAVE ANY PHYSICAL SAMPLES THAT YOU COULD RETURN FOR EVALUATION? NO, THE PHOTOS SENT WITH THE INCIDENT IS WHAT WE HAVE. THERE ARE NO OTHER SAMPLES. DID THE PERSON WHO WAS STUCK WITH THE NEED SEEK ANY MEDICAL ATTENTION? YES. WOULD YOU PLEASE BE ABLE TO PROVIDE US WITH PATIENT IDENTIFIERS? NO.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11293133 ↗