BD Nexiva 383551Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00382903835515), received between May 21, 2018 and Apr 24, 2026 — classified as 1 death, 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Material Integrity Problem

  IT WAS REPORTED BY CUSTOMER THAT NEEDLE THROUGH CATHETER WALL, OCCURRED DURING INSERTION. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE THROUGH CATHETER WALL OCCURRED DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984232 ↗
• MalfunctionApr 20, 2026Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT THEY JUST FLUSHED THIS ONE AND ITS LEAKING WHERE THE CATHETER MEETS THE CLEAR PLASTIC HUB AT THE WINGS LEAKING AND HAVE TO RESTART LINE. VERBATIM: COMPLAINT VIA EMAIL. "I JUST FLUSHED THIS ONE AND ITS LEAKING WHERE THE CATHETER MEETS THE CLEAR PLASTIC HUB AT THE WINGS. LEAKING AND HAVE TO RESTART LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927856 ↗
• MalfunctionApr 17, 2026Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING HAD A HOLE. INJURIES OR ADVERSE EVENT: YES REPORTED ISSUE: 24 G PIV MALFUNCTIONED DURING A PIV PLACEMENT ON 3 Y/O PATIENT REQUIRING NEED FOR ADDITIONAL IV ACCESS D/T DEVICE MALFUNCTION. ADDITIONAL INFORMATION 4/6/2026 CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? DATE OF EVENT: 3/24/2026 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE NOTED. ADDITIONAL INFORMATION 4/10/2026: IT IS STATED THAT " 24 G PIV MALFUNCTIONED DURING A PIV PLACEMENT ON 3 Y/O PATIENT REQUIRING NEED FOR ADDITIONAL IV ACCESS D/T DEVICE MALFUNCTION." PLEASE DESCRIBE THE "MALFUNCTION. "TUBING FROM PIV DEVICE TO EXTENSION CONNECTION HAD A HOLE, SO WHEN WE CHECKED FOR PATENCY THERE WAS LEAKING FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913801 ↗
• MalfunctionMar 3, 2026Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT NOTICED IT WAS WET - DURING HER ASSESSMENT SHE DETERMINED IT WAS NOT LEAKING FROM THE SITE - BUT RATHER FROM WHERE THE TUBING CONNECTS TO THE YELLOW END PIECE THAT CONNECTS TO MAXZERO. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. A NURSE AT OUR LHAP LOCATION SHARED WITH ME HER CONCERNS REGARDING THIS DEVICE THAT OCCURRED LAST NIGHT. SHE WAS ASSESSING HER CHILD'S IV AND NOTICED IT WAS WET - DURING HER ASSESSMENT SHE DETERMINED IT WAS NOT LEAKING FROM THE SITE - BUT RATHER FROM WHERE THE TUBING CONNECTS TO THE YELLOW END PIECE THAT CONNECTS TO MAXZERO. SHE FORGOT TO KEEP THE IV CATHETER FOR ME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497063 ↗
• MalfunctionMar 3, 2026Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT ASSESSING HER CHILD'S IV AND NOTICED IT WAS WET. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. A NURSE AT OUR XX LOCATION SHARED WITH ME HER CONCERNS REGARDING THIS DEVICE THAT OCCURRED LAST NIGHT. SHE WAS ASSESSING HER CHILD'S IV AND NOTICED IT WAS WET - DURING HER ASSESSMENT SHE DETERMINED IT WAS NOT LEAKING FROM THE SITE - BUT RATHER FROM WHERE THE TUBING CONNECTS TO THE YELLOW END PIECE THAT CONNECTS TO MAXZERO. SHE FORGOT TO KEEP THE IV CATHETER FOR ME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497062 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT TWICE IN ONE DAY A 24 GAUGE IV WAS USED TO INSERT A PIV ON A PATIENT AND BOTH TIMES THE CLEAR CAP WAS MISSING AT THE END SO THERE WAS NO BACKFLOW STOP AND THE BLOOD ENDED UP DRIPPING OUT OF THE END. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT PROBLEM REPORT PRODUCT INFORMATION PRODUCT CODE: 383511 PRODUCT DESCRIPTION: CATHETER IV CLOSED NEXIVA 24G X & 0.75IN W/SINGLE PORT BX/20 LOT/SERIAL #: (B)(6) EXPIRY DATE: UNKNOWN PROBLEM INFORMATION PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: (B)(6) 2026 CONCERN DESCRIPTION: TWICE IN ONE DAY A 24 GAUGE IV WAS USED TO INSERT A PIV ON A PATIENT AND BOTH TIMES THE CLEAR CAP WAS MISSING AT THE END SO THERE WAS NO BACKFLOW STOP AND THE BLOOD ENDED UP DRIPPING OUT OF THE END. OCCURRENCES: 1 EACH REPORTER INFORMATION SITE INFORMATION SAMPLE INFORMATION INCIDENT SAMPLES: 0 REPRESENTATIVE SAMPLES: 0 NO ADVERSE EVENT REPORTED ADDITIONAL INFORMATION: WHAT WAS THE IMPACT TO THE PATIENT? PT BLED SLIGHTLY MORE THAN USUAL WITH INSERTION, MINIMAL IMPACT. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? UNFORTUNATELY, NO PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304955 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THE CLEAR END CAP WAS NOT ATTACHED TO THE IV AND WAS LOOSE INSIDE OF THE PACKAGE. AS A RESULT, THE IV HAS DRIPPED BLOOD OUT OF THE LINE AFTER IT IS PLACED. RCC RECEIVED A COMPLAINT VIA EMAIL. OVER THE LAST WEEK, WE HAVE HAD 5 INSTANCES OF THE 24G YELLOW BD NEXIA IV KITS WHERE THE CLEAR END CAP WAS NOT ATTACHED TO THE IV AND WAS LOOSE INSIDE OF THE PACKAGE. AS A RESULT, THE IV HAS DRIPPED BLOOD OUT OF THE LINE AFTER IT IS PLACED. THIS HAS BEEN SEEN BY 4 DIFFERENT NURSES WHEN STARTING 24G IVS. PICTURES ATTACHED. PT CODE: 4582. DEVICE CODES: 1250, 2912. REF REPORTS: MW5181269, MW5181270, MW5181271, MW5181273.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292673 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THE CLEAR END CAP WAS NOT ATTACHED TO THE IV AND WAS LOOSE INSIDE OF THE PACKAGE. AS A RESULT, THE IV HAS DRIPPED BLOOD OUT OF THE LINE AFTER IT IS PLACED. RCC RECEIVED A COMPLAINT VIA EMAIL. OVER THE LAST WEEK, WE HAVE HAD 5 INSTANCES OF THE 24G YELLOW BD NEXIA IV KITS WHERE THE CLEAR END CAP WAS NOT ATTACHED TO THE IV AND WAS LOOSE INSIDE OF THE PACKAGE. AS A RESULT, THE IV HAS DRIPPED BLOOD OUT OF THE LINE AFTER IT IS PLACED. THIS HAS BEEN SEEN BY 4 DIFFERENT NURSES WHEN STARTING 24G IVS. PT CODE: 4582. DEVICE CODES: 1250, 2912. REF REPORTS: MW5181269, MW5181270, MW5181271, MW5181272.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292644 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT WHERE THE CLEAR END CAP WAS NOT ATTACHED TO THE IV AND WAS LOOSE INSIDE OF THE PACKAGE. AS A RESULT, THE IV HAS DRIPPED BLOOD OUT OF THE LINE AFTER IT IS PLACED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. OVER THE LAST WEEK, WE HAVE HAD 5 INSTANCES OF THE 24G YELLOW BD NEXIA IV KITS WHERE THE CLEAR END CAP WAS NOT ATTACHED TO THE IV AND WAS LOOSE INSIDE OF THE PACKAGE. AS A RESULT, THE IV HAS DRIPPED BLOOD OUT OF THE LINE AFTER IT IS PLACED. THIS HAS BEEN SEEN BY 4 DIFFERENT NURSES WHEN STARTING 24G IVS. PT CODE: 4582. DEVICE CODES: 1250, 2912. MW5181269, MW5181271, MW5181272, MW5181273.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279297 ↗
• MalfunctionFeb 6, 2026Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT WHERE THE CLEAR END CAP WAS NOT ATTACHED TO THE IV AND WAS LOOSE INSIDE OF THE PACKAGE. AS A RESULT, THE IV HAS DRIPPED BLOOD OUT OF THE LINE AFTER IT IS PLACED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. OVER THE LAST WEEK, WE HAVE HAD 5 INSTANCES OF THE 24G YELLOW BD NEXIA IV KITS WHERE THE CLEAR END CAP WAS NOT ATTACHED TO THE IV AND WAS LOOSE INSIDE OF THE PACKAGE. AS A RESULT, THE IV HAS DRIPPED BLOOD OUT OF THE LINE AFTER IT IS PLACED. THIS HAS BEEN SEEN BY 4 DIFFERENT NURSES WHEN STARTING 24G IVS. PT CODE: 4582. DEVICE CODES: 1250, 2912. MW5181269, MW5181271, MW5181272, MW5181273.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279279 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  OVER THE LAST WEEK, WE HAVE HAD 5 INSTANCES OF THE 24G YELLOW BD NEXIA IV KITS WHERE THE CLEAR END CAP WAS NOT ATTACHED TO THE IV AND WAS LOOSE INSIDE OF THE PACKAGE. AS A RESULT, THE IV HAS DRIPPED BLOOD OUT OF THE LINE AFTER IT IS PLACED. 1/26/2026: NO SERIOUS ADVERSE EVENTS OR INJURIES ASSOCIATED WITH THIS CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261173 ↗
• MalfunctionJan 6, 2026Retraction Problem

  IT WAS REPORTED THAT BD NEXIVA 24 GA X 0.75IN SP WITH MAXZERO NEEDLE RETRACTION FAILED IT WAS REPORTED BY THE CUSTOMER THAT FLASHBACK NOTED BUT UNABLE TO ADVANCE THEREFORE REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE NEEDLE DID NOT RETRACT ALL THE WAY AND HAD PUNCTURED THE CATHETER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. IV INSERTED. FLASHBACK NOTED BUT UNABLE TO ADVANCE THEREFORE REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE NEEDLE DID NOT RETRACT ALL THE WAY AND HAD PUNCTURED THE CATHETER. ITEM - 383551 LOT - 5136556.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979870 ↗
• MalfunctionNov 24, 2025Backflow; Leak/Splash; Backflow; Leak/Splash

  BLOOD LEAKING FROM THE MIDDLE OF THE BUILT-IN EXTENSION TUBING CAUSING BACK FLOW. PLEASE NOTE: BLOOD IN TUBING AS IV WAS USED. IV TAKEN OUT. 2ND SITE CHOSEN FOR NEW IV PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638673 ↗
• MalfunctionNov 17, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23571900 ↗
• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO TUBING DAMAGE WITH LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOLE IN EXTENSION SET ON NEXIVA. FLUID COMING THROUGH WHEN PUSHING NEEDED TO DC LINE AND START NEW IV. I SUBMITTED 2 COMPLAINTS AND MAILED IN 2 DEVICES, HOWEVER WE HAVE AT LEAST 5 DIFFERENT PATIENT SAFETY EVENTS INVOLVING 4 PATIENTS. NOT SURE OF THE SPECIFICS OF EACH, BUT 2 OF THE PATIENT REQUIRED ADDITIONAL STICKS TO REPLACE THE DEFECTIVE DEVICE. WE HAVE ASKED OUR STAFF TO REPORT ANY LEAKING, COMPLETE A SAFETY EVENT. I HAVE NOT HEARD OF ANY IN THE COUPLE OF DAYS BUT I ALSO DON'T SEE ALL THE SAFETY EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636917 ↗
• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO TUBING DAMAGE WITH LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOLE IN EXTENSION SET ON NEXIVA. FLUID COMING THROUGH WHEN PUSHING NEEDED TO DC LINE AND START NEW IV. I SUBMITTED 2 COMPLAINTS AND MAILED IN 2 DEVICES, HOWEVER WE HAVE AT LEAST 5 DIFFERENT PATIENT SAFETY EVENTS INVOLVING 4 PATIENTS. NOT SURE OF THE SPECIFICS OF EACH, BUT 2 OF THE PATIENT REQUIRED ADDITIONAL STICKS TO REPLACE THE DEFECTIVE DEVICE. WE HAVE ASKED OUR STAFF TO REPORT ANY LEAKING, COMPLETE A SAFETY EVENT. I HAVE NOT HEARD OF ANY IN THE COUPLE OF DAYS BUT I ALSO DON¿T SEE ALL THE SAFETY EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636876 ↗
• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO TUBING DAMAGE WITH LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOLE IN EXTENSION SET ON NEXIVA. FLUID COMING THROUGH WHEN PUSHING NEEDED TO DC LINE AND START NEW IV. I SUBMITTED 2 COMPLAINTS AND MAILED IN 2 DEVICES, HOWEVER, WE HAVE AT LEAST 5 DIFFERENT PATIENT SAFETY EVENTS INVOLVING 4 PATIENTS. NOT SURE OF THE SPECIFICS OF EACH, BUT 2 OF THE PATIENTS REQUIRED ADDITIONAL STICKS TO REPLACE THE DEFECTIVE DEVICE. WE HAVE ASKED OUR STAFF TO REPORT ANY LEAKING, COMPLETE A SAFETY EVENT. I HAVE NOT HEARD OF ANY IN THE COUPLE OF DAYS BUT I ALSO DON¿T SEE ALL THE SAFETY EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636729 ↗
• MalfunctionJan 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WENT TO START THE PATIENT IV FOR TREATMENT. RN INSERTED THE ANGIOCATH AND WHEN SHE WENT TO WITHDRAW THE NEEDLE FROM THE ANGIOCATH. PATIENT COMPLAINED OF PAIN AND WHEN NURSE PULLED THE IV SHE FOUND THAT THE NEEDLE HAD GONE THROUGH THE PLASTIC SHEATH, ANGIOCATH WAS A 24 GAUGE X 0.75 IN BD NEXIVA. LOT NUMBER WAS 4215289. THIS IS THE SECOND INCIDENCE OF THIS, THIS WEEK BY 2 DIFFERENT RN'S.

  Patient problems: Insufficient Information

  MAUDE report 21125295 ↗
• MalfunctionDec 5, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WENT TO START THE PATIENT IV FOR TREATMENT. RN INSERTED THE ANGIOCATH AND WHEN SHE WENT TO WITHDRAW THE NEEDLE FROM THE ANGIOCATH. PATIENT COMPLAINED OF PAIN AND WHEN NURSE PULLED THE IV SHE FOUND THAT THE NEEDLE HAD GONE THROUGH THE PLASTIC SHEATH, ANGIOCATH WAS A 24 GAUGE X 0.75 IN BD NEXIVA. LOT NUMBER WAS 4215289. THIS IS THE SECOND INCIDENCE OF THIS, THIS WEEK BY 2 DIFFERENT RN'S. (B)(6). PLEASE PROVIDE THE DATE OF EVENT. 11/15/24.

  Patient problems: Pain

  MAUDE report 20854775 ↗
• MalfunctionNov 13, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO CATHETER CRACKS AND IS DIFFICULT TO DISENGAGE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT # 4215289 CRACKING IN OUR OP INFUSION AREA. LOSS OF IV. CUSTOMER RESPONSE ON OCT 28, 2024. THIS IS WHAT WE RECEIVED FROM OUR END USER. ¿WE HAVE IDENTIFIED 4 IV STARTS WITH THIS SAME LOT # TO HAVE PROBLEMS WHEN WE INSERT THE NEEDLE. IT SEEMS DIFFICULT TO PULL THE NEEDLE OUT AND THEN THE IV DOES NOT WORK AND WHEN WE PULL THE CATHETER IT IS CRACKED AND BENT ABOUT MIDWAY THROUGH. NONE OF THEM BROKE OFF BUT IT WAS CLEARLY BENT AND CRACKED. WE DID PULL ALL OF THEM OFF THE SHELF WITH THE SAME LOT # 4215289.¿

  Patient problems: Insufficient Information

  MAUDE report 20677566 ↗
• MalfunctionNov 12, 2024Crack; Crack

  IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO CATHETER CRACKS AND IS DIFFICULT TO DISENGAGE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT # 4215289 CRACKING IN OUR OP INFUSION AREA. LOSS OF IV. CUSTOMER RESPONSE ON OCT 28, 2024. THIS IS WHAT WE RECEIVED FROM OUR END USER. ¿WE HAVE IDENTIFIED 4 IV STARTS WITH THIS SAME LOT # TO HAVE PROBLEMS WHEN WE INSERT THE NEEDLE. IT SEEMS DIFFICULT TO PULL THE NEEDLE OUT AND THEN THE IV DOES NOT WORK AND WHEN WE PULL THE CATHETER IT IS CRACKED AND BENT ABOUT MIDWAY THROUGH. NONE OF THEM BROKE OFF BUT IT WAS CLEARLY BENT AND CRACKED. WE DID PULL ALL OF THEM OFF THE SHELF WITH THE SAME LOT # 4215289.¿

  Patient problems: Insufficient Information

  MAUDE report 20662099 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THE BD NEXIVA 24 GA X 0.75IN SP WITH MAXZERO NEEDLE THROUGH CATHETER IT WAS REPORTED BY CUSTOMER THAT THEY STARTED AN IV ON THE PATIENT, AND AS I WAS PULLING THE NEEDLE OUT, THE NEEDLE BROKE THE PLASTIC CATHETER, AND THIS OCCURRED 3 TIMES. VERBATIM: THERE WAS AN ISSUE WITH A NEXIVA IV START, PLEASE SEE INFORMATION BELOW: STARTED AN IV ON THE PATIENT, AND AS I WAS PULLING THE NEEDLE OUT, THE NEEDLE BROKE THE PLASTIC CATHETER, AND THIS OCCURRED 3 TIMES. NURSE DENIES DEVIATING FROM HER TYPICALLY INSERTION TECHNIQUE AND STATES SHE DID NOT TRY TO RE-THREAD THE NEEDLE. THESE WERE BD NEXIVA 24-GAUGE X 0.75 IN IV CATHETERS. LOT NUMBER 4059677, DATE OF MANUFACTURE 2024-03-01. EXPIRATION 2027-02-28. THERE IS ANOTHER NUMBER ON THE PACKAGE, UNSURE WHAT IT IS BUT WILL INCLUDE IN CASE IT IS HELPFUL (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726732 ↗
• InjurySep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿ THE NEEDLE DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CITE CUSTOMER REF# (B)(4) CONCERN DESCRIPTION: PROTECTIVE GREY COVER DID NOT STAY ON NEEDLE ONCE NEEDLE WAS WITHDRAWN FROM PATIENT, RESULTING IN RN BEING STUCK BY NEEDLE. SAFETY DEVICE DID NOT OPERATE AS IT SHOULD OCCURRENCES: 1 EACH. DATE OF EVENT: (B)(6) 2023. WHAT PROCEDURE WAS BEING PERFORMED? PERIPHERAL IV INSERTION. WHAT MEDICATION WAS USED IN THE PROCEDURE? NIL. WAS THERE ANY MEDICAL INTERVENTION DUE TO NEEDLE STICK INJURY ON RN? RN CHECKED IN TO ED FOR FIRST AID AND TRIAGE (UNSURE WHAT LEVEL OF BBF SHE WAS CONSIDERED). IS SAMPLE AVAILABLE FOR RETURN TO BD FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE SENDER¿S NAME AND ADDRESS FOR US TO CREATE THE FEDEX RETURN LABEL. IF SAMPLE IS NOT AVAILABLE, ARE YOU ABLE TO PROVIDE PHOTO(S) OF THE SAMPLE?

  Patient problems: Needle Stick/Puncture

  MAUDE report 17753130 ↗
• MalfunctionJul 8, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿ EXPERIENCED A SAFETY MECHANISM THAT WOULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE NURSE INSERTED THE IV SHE WAS RETRACTING THE NEEDLE AND THE SAFETY MECHANISM MALFUNCTIONED AND HAD AN EXPOSED NEEDLE. THE EXPOSED NEEDLE THEN SCRAPED ACROSS THE TOP OF THE NURSES HAND.

  Patient problems: Abrasion

  MAUDE report 14959502 ↗
• MalfunctionJan 31, 2022Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT WITH MAXZERO¿ THE TUBING WAS FOUND TO BE DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL# 383551, IT WAS REPORTED TUBING IS DAMAGED LOT# UNKNOWN PER CUSTOMER. EXTENSION TUBING LOOKS TO BE DILATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13402283 ↗