Safe-TRecalls & reported problems across all models

We found 9 models of Safe-T by Carefusion 2200, Inc in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Jul 9, 2020 and Nov 18, 2024 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (5 reports).

8 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Safe-T recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 20, 2022Open, Classified

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

   Z-0800-2022 · Root cause: Process control · Recall details · FDA record ↗

2. Jan 20, 2022Open, Classified

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

   Z-0797-2022 · Root cause: Process control · Recall details · FDA record ↗

3. Jan 20, 2022Open, Classified

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

   Z-0794-2022 · Root cause: Process control · Recall details · FDA record ↗

4. Jan 20, 2022Open, Classified

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

   Z-0790-2022 · Root cause: Process control · Recall details · FDA record ↗

5. May 28, 2020Terminated

   The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

   Z-2659-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. May 28, 2020Terminated

   The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

   Z-2658-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. May 28, 2020Terminated

   The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

   Z-2656-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. May 28, 2020Terminated

   The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

   Z-2655-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Safe-T problems

Safe-T models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Safe-T 4301CSP

  Lumbar puncture tray (adult & pediatric)
  1 recall7 reports
• Safe-T 4306CWSP

  Lumbar puncture tray (adult & pediatric)
  1 recall7 reports
• Safe-T TPT1000SP

  Thoracentesis tray
  1 recall6 reports
• Safe-T TPT1005SP

  Thoracentesis tray
  1 recall1 report
• Safe-T 4302CSP

  Lumbar puncture tray (adult & pediatric)
  1 recall0 reports
• Safe-T 4306CSP

  Lumbar puncture tray (adult & pediatric)
  1 recall0 reports
• Safe-T TPT1000SDF

  Thoracentesis tray
  1 recall0 reports
• Safe-T TPT1005SDF

  Thoracentesis tray
  1 recall0 reports
• Safe-T OTP5000SP

  Thoracentesis tray
  5 reports

Recent Safe-T adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2024Contamination; Contamination

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS DEBRIS IN ONE OF THE TEST TUBES IN THE KIT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED NOTICED THAT THERE WAS DEBRIS IN ONE OF THE TEST TUBES IN THE KIT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PARACENTESIS. PRODUCT NUMBER - TPT1000SP CUSTOMER RESPONSE ON NOV 11, 2024 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE DEBRIS? NO ADDITIONAL INFORMATION PROVIDED. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? AFTER COMPLETING PROCEDURE. 3. WHAT WAS THE IMPACT TO THE PATIENT? NONE 4. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 5. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 08-19-2024 6. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE?0001569804 7. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708380 ↗
• MalfunctionNov 1, 2024

  NOTICED THAT THERE WAS DEBRIS IN ONE OF THE TEST TUBES IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587064 ↗
• MalfunctionJul 18, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE INTRODUCER NEEDLE BROKE DURING THE PROCEDURE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE INTRODUCER NEEDLE BROKE DURING THE PROCEDURE. THEY HAD TO OPEN ANOTHER TRAY TO COMPLETE THE PROCEDURE. PRODUCT NUMBER - TPT1000SP. LOT NUMBER - 00018559052. DESCRIBE PATIENT / HCP / USER IMPACT - OPENED ANOTHER TRAY TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771467 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. HAVE YOU HEARD ANY OTHER COMPLAINS OR ISSUES RELATED TO THIS?

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712387 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. HAVE YOU HEARD ANY OTHER COMPLAINS OR ISSUES RELATED TO THIS? FOLLOW-UP: CUSTOMER RESPONSE ON (B)(6) 2024 : 1. CAN YOU PLEASE PROVIDE A EXACT DATE OF EVENT? I DO NOT HAVE EXACT DATES. I JUST KNOW IT HAS OCCURRED A FEW SEPARATE TIMES WITH 3 DIFFERENT PHYSICIANS REPORTING ISSUES. 2. TOTAL NUMBER OF EVENTS? (B)(4). 3. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? IF YES, WHAT WAS THE IMPACT TO THE PATIENT? YES, THIS OCCURRED DURING PROCEDURES. IT R

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712385 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM REACHING OUT TO YOU IN REGARDS TO AN ISSUE THAT 3 OF OUR PULMONARY CRITICAL CARE PROVIDERS HAVE BROUGHT TO MY ATTENTION INVOLVING THE THORA/PARA DRAINAGE TRAYS (OTP5000SP). THEY ARE HAVING ISSUES WITH THE TUBE COLLAPSING ON ITSELF WHICH THEN REQUIRES THEM TO OBTAIN A 2ND KIT TO USE IN THE MIDDLE OF PROCEDURES. HAVE YOU HEARD ANY OTHER COMPLAINS OR ISSUES RELATED TO THIS?

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712219 ↗
• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT THERE'S BEEN AN INTERMITTENT ISSUE WITH THE 25G X 1' NEEDLE IN THESE TRAYS TYPICALLY WE ARE ABLE TO DRAW BACK AIR AND THEN IT WILL WORK. THE ONE IN THIS TRAY DID NOT FUNCTION I WASN'T ABLE TO ASPIRATE AIR INTO THE SYRINGE OR ABLE PUSH AIR OUT THROUGH THE 25G. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THERE'S BEEN AN INTERMITTENT ISSUE WITH THE 25G X 1' NEEDLE IN THESE TRAYS TYPICALLY WE ARE ABLE TO DRAW BACK AIR AND THEN IT WILL WORK. THE ONE IN THIS TRAY DID NOT FUNCTION I WASN'T ABLE TO ASPIRATE AIR INTO THE SYRINGE OR ABLE PUSH AIR OUT THROUGH THE 25G

  Patient problems: Insufficient Information

  MAUDE report 18114833 ↗
• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT THIS ISSUE HAS BEEN PRESENT FOR THE PAST 6-8 WEEKS WE THINK IT WAS THE SAME TIME THAT THE LIDOCAINE WAS NOT INCLUDED IN THE TRAY. THE PROVIDED BD SAFETYGLIDE NEEDLE 25 G X 1' HAS BEEN OCCLUDED AND WE ARE UNABLE TO SQUIRT THE AIR OUT OF THE SYRINGE/PRIME THE NEEDLE WITH LIDOCAINE. OTHER TIMES IT IS DIFFICULT BUT THEN IF YOU DRAW MORE AIR INTO THE SYRINGE WITH THE NEEDLE ATTACHED THEN IT WILL PRIME AS USUAL OR WITH SLIGHT DIFFICULTY. IT HAS BEEN INCONSISTENT AMONGST THE TRAYS. THE PROVIDED LOT NUMBER IS FROM A TRAY TODAY 4/20 THAT THIS ISSUE WAS PRESENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS ISSUE HAS BEEN PRESENT FOR THE PAST 6-8 WEEKS WE THINK IT WAS THE SAME TIME THAT THE LIDOCAINE WAS NOT INCLUDED IN THE TRAY. THE PROVIDED BD SAFETYGLIDE NEEDLE 25 G X 1' HAS BEEN OCCLUDED AND WE ARE UNABLE TO SQUIRT THE AIR OUT OF THE SYRINGE/PRIME THE NEEDLE WITH LIDOCAINE. OTHER TIMES IT IS DIFFICULT BUT THEN IF YOU DRAW MORE AIR INTO THE SYRINGE WITH THE NEEDLE ATTACHED THEN IT WILL PRIME AS USUAL OR WITH SLIGHT DIFFICULTY. IT HAS BEEN INCONSISTENT AMONGST THE TRAYS.

  Patient problems: Insufficient Information

  MAUDE report 18112133 ↗
• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT WHEN ATTEMPTING TO DRAW BACK AND PRIME INCLUDED BD SAFETY GLIDE 25G X 1' NEEDLE WITH LIDOCAINE UNABLE TO ASPIRATE AIR THROUGH NEEDLE UNABLE TO EXPEL AIR OR PRIME NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN ATTEMPTING TO DRAW BACK AND PRIME INCLUDED BD SAFETY GLIDE 25G X 1' NEEDLE WITH LIDOCAINE UNABLE TO ASPIRATE AIR THROUGH NEEDLE UNABLE TO EXPEL AIR OR PRIME NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 18111907 ↗
• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE USED FOR LIDOCAINE ADMINISTRATION FOR LP WAS OCCLUDED. UNABLE TO PUSH AIR OR LIDOCAINE THROUGH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE USED FOR LIDOCAINE ADMINISTRATION FOR LP WAS OCCLUDED. UNABLE TO PUSH AIR OR LIDOCAINE THROUGH.

  Patient problems: Insufficient Information

  MAUDE report 18111758 ↗
• MalfunctionNov 10, 2023Contamination; Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT TUBE/VILE #1 PROVIDED IN THIS LUMBAR PUNCTURE KIT HAD A FOREIGN BODY (FB) IN IT. INITIALLY, CUSTOMER THOUGHT IT WAS JUST THE WAY THE TUBES LOOK DUE TO LIGHT REFLECTING. THEN AS CSF BEGAN TO COLLECT THE FOREIGN BODY BEGAN TO FLOAT AND APPEARS AS A BLACK SPECK OF DEBRIS. THE FB THEN SINKS AND CAN BE SEEN AT THE VERY BOTTOM OF THE TUBE. CENTRAL PROCESSING WAS MADE AWARE AND A SPECIMEN NOTE WAS ENTERED IN NOTING THE PRESENCE OF THE FOREIGN BODY AND THAT THIS TUBE SHOULD BE STORED/KEPT AND NOT UTILIZED FOR TESTING UNLESS ABSOLUTELY NECESSARY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. TUBE/VILE #1 PROVIDED IN THIS LUMBAR PUNCTURE KIT HAD A FOREIGN BODY (FB) IN IT. INITIALLY, I THOUGHT IT WAS JUST THE WAY THE TUBES LOOK DUE TO LIGHT REFLECTING. THEN AS CSF BEGAN TO COLLECT THE FB BEGAN TO FLOAT AND APPEARS AS A BLACK SPECK OF DEBRIS. THE FB THEN SINKS AND CAN BE SEEN AT THE VERY BOTTOM OF THE TUBE. CENTRAL PROCESSING WAS MADE AWARE AND A SPECIMEN NOTE WAS ENTERED IN NOTING THE PRESENCE OF THE FOREIGN BODY AND THAT THIS TUBE SHOULD BE STORED/KEPT AND NOT UTILIZED FOR TESTING UNLESS ABSOLUTELY NECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 18111131 ↗
• InjuryNov 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT THE THREE-WAY STOPCOCK FROM LP TRAY WITH LOT # 0001450952 - THE STOPCOCK WAS OCCLUDED OR THE HOLES THAT ALLOW THE FLUID TO FLOW WERE NON-PATENT AS THE CSF HAD SPONTANEOUS AND CONSISTENT FLOW WITHOUT ANY DIFFICULTY BUT THEY WOULD NOT FILL THE STOPCOCK AS USUAL AND THEREFORE WOULD NOT FLOW THROUGH AND ALLOW FOR PRESSURE MEASUREMENT WITH THE INCLUDED MANOMETER BUT THE CSF WOULD ALSO NOT FLOW OUT THE OPEN PORT OF THE STOPCOCK. LOT # 0001452437 - LEAKED UNABLE TO OBTAIN ACCURATE PRESSURE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE THREE-WAY STOPCOCK FROM LP TRAY WITH LOT # 0001450952 - THE STOPCOCK WAS OCCLUDED OR THE HOLES THAT ALLOW THE FLUID TO FLOW WERE NON-PATENT AS THE CSF HAD SPONTANEOUS AND CONSISTENT FLOW WITHOUT ANY DIFFICULTY BUT THE WOULD NOT FILL THE STOPCOCK AS USUAL AND THEREFORE WOULD NOT FLOW THROUGH AND ALLOW FOR PRESSURE MEASUREMENT WITH THE INCLUDED MANOMETER BUT THE CSF WOULD ALSO NOT FLOW OUT THE OPEN PORT OF THE STOPCOCK. LOT # 0001452437 - LEAKED UNABLE TO OBTAIN ACCURATE PRESSURE FURTHER DETAILS COULD BE OBTAINED FROM XXX

  Patient problems: Insufficient Information

  MAUDE report 18111016 ↗
• InjuryFeb 8, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED BY THE CUSTOMER THAT ONE NEEDLE COME NOT PATENT AND A SEPARATE KIT COME WITH THE SPINAL NEEDLE FUSED. VERBATIM: I HAVE HAD A RASH OF FAULTY LUMBAR PUNCTURE KITS AND UNFORTUNATELY ONE YESTERDAY RESULTED IN ME GETTING STUCK WITH A DIRTY NEEDLE. I AM HOPING THAT SOMEONE CAN RESPOND TO THIS ASAP AS THIS WAS NOT AN ISOLATED INCIDENT AND I THINK WE NEED TO CONSIDER AN ALTERNATIVE MANUFACTURER. TWO WEEKS AGO, IN TWO SEPARATE KITS I HAD ONE NEEDLE COME NOT PATENT AND A SEPARATE KIT COME WITH THE SPINAL NEEDLE FUSED. BOTH OF THEM HAD THE SAME LOT NUMBER (LISTED BELOW). YESTERDAY, I RECEIVED A KIT THAT HAD A FOAM NEEDLE STOP THAT WAS NOT ADHERED TO THE BOTTOM OF THE TRAY (SO IT CAME OUT WHEN I PUT A NEEDLE IN IT). I PUT THE PLASTIC CAP FLAT ON THE TRAY AND SLID THE NEEDLE IN. I MOVED THE NEEDLE VERTICALLY TO SECURE THE CAP AND THE CAP POKED THROUGH THE TOP OF THE PLASTIC CAP. THIS KIT WAS THE SAME LOT NUMBER AS THE INCIDENTS LISTED ABOVE. IT IS MY OPINION THAT THIS KIT SHOULD BE REMOVED FROM THE HOSPITAL IMMEDIATELY OR THERE WILL CONTINUE TO BE PEOPLE ACCIDENTLY GETTING POKED. CAN WE PLEASE GET AN ALTERNATIVE MANUFACTURER? THIS WAS A BD/CAREFUSION KIT (LOT 0001482141, EXP 7/3

  Patient problems: Needle Stick/Puncture

  MAUDE report 16326030 ↗
• MalfunctionJan 24, 2023Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  FOAM NEEDLE STOP WAS NOT ADHERED TO THE BOTTOM OF THE TRAY, SO IT CAME OUT WHEN NEEDLE WAS PLACED IN IT. 22-GAUGE NEEDLES IN USE. STAFF MEMBER PUT THE PLASTIC CAP FLAT ON THE TRAY AND SLID THE NEEDLE IN. SHE MOVED THE NEEDLE VERTICALLY TO SECURE THE CAP AND THE CAP POKED THROUGH THE TOP OF THE PLASTIC CAP. EMPLOYEE NEEDLESTICK INJURY OCCURRED. TWO PRIOR INCIDENTS WITH THIS LOT DID NOT RESULT IN EMPLOYEE INJURY. MANUFACTURER RESPONSE FOR LUMBAR PUNCTURE TRAY (ADULT PEDIATRIC), SAFE-T (PER SITE REPORTER). "I WILL BE FORWARDING THIS ON TO OUR FIELD ASSURANCE TEAM. EVEN THOUGH WE ARE NO LONGER SELLING THIS ITEM, WE DO INDEED NEED TO BE MADE OF ANY ADVERSE EVENTS. THANK YOU."

  Patient problems: Needle Stick/Puncture

  MAUDE report 16234216 ↗
• InjuryNov 17, 2022Component Missing; Component Missing

  IT WAS REPORTED BY THE CUSTOMER THAT THE STOP COCK TURN DIAL WAS MISSING AND WHEN THE PHYSICAL PUNCTURE OCCURRED IT ALLOWED AIR INTO THE CAVITY CAUSING PATIENT HARM. PRODUCT NAME: SAFE-T PLUS THORA-PARA TRAYS. PATIENT HARM: IT WAS MISSING THE STOP COCK TURN DIAL, SO WHEN THE PHYSICAL PUNCTURE AND IT ALLOW THE AIR IN THE CAVITY CAUSING HARM TO THE PATIENT. PATIENT HARM REQUIRE FURTHER INTERVENTION: A TUBE. DATE OF EVENT: (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED 14-NOV-2022. WHAT WAS THE PROCEDURE BEING PERFORMED? THORACENTESIS. WAS THERE PATIENT HARM/IMPACT? YES, PATIENT REQUIRED CHEST TUBE PLACEMENT NEXT DAY DUE TO PNEUMOTHORAX, AND THEN LATER TRANSFER TO HLOC FOR CARDIOTHORACIC SURGERY. WAS THE PROCEDURE ABLE TO BE COMPLETED, WHAT WAS DONE TO COMPLETE IT? YES, A NEW KIT WAS OPENED TO OBTAIN THE SUPPLY WITH STOPCOCK IN PLACE. DO YOU HAVE ANY PHOTOS SHOWING THE REPORTED ISSUE.? YES. PLEASE USE THE ATTACHED PREPAID SHIPPING LABEL TO RETURN THE AFFECTED PRODUCT. OUR QUALITY DEPARTMENT WILL RETAIN THE DEFECTIVE UNIT AS IT WAS USED FOR PATIENT CARE PRIOR TO THE DISCOVERY OF MISSING PIECES AND DID CAUSE HARM TO THE PATIENT.

  Patient problems: Pneumothorax

  MAUDE report 15818285 ↗

Other Carefusion 2200, Inc products

• V. Mueller47 models · 2 reports · 18 recalls
• Safe-T-Centesis7 models · 217 reports · 7 recalls
• PleurX14 models · 388 reports
• Jamshidi18 models · 53 reports · 4 recalls
• Surgiphor2 models · 171 reports
• PeritX5 models · 59 reports