BD Nexiva 383518Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00382903835188), received between Apr 11, 2018 and Jan 28, 2025 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Material Separation; Material Separation

  EVENT DATE UPDATED TO UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21256882 ↗
• MalfunctionAug 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD NEXIVA SINGLE PORT FOREIGN MATTER FOUND ON CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: BEFORE USE WHEN OPENING THE PACKAGING, THE USER FOUND SOILING IN THE PACKAGING AND ON THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072276 ↗
• MalfunctionMar 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950555 ↗
• MalfunctionMar 8, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18868333 ↗
• MalfunctionFeb 7, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT TWO BD NEXIVA 20 GA X 1-3/4 IN SINGLE PORTS WERE MISSING THE LABEL CONTENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO NEXIVA CATHETER PACKAGES DID NOT HAVE ANYTHING PRINTED ON THE FRONT WHEN RECEIVED BY CUSTOMER. THE REMAINDER OF THE BOX WAS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663804 ↗
• MalfunctionNov 24, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT BD NEXIVA NEEDLE WAS DIFFICULT TO DISENGAGE FROM THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION: I ATTEMPTED TO START AN IV ON A PT AND WHEN TRYING TO LOOSEN THE CONNECTIONS ON THE CATHETER, I NOTICED THAT IT WAS SIGNIFICANTLY MORE DIFFICULT THAT IT USUALLY IS. HAD I STARTED THE IV ON THE PT WITHOUT CHECKING. I WOULD HAVE NOT BEEN ABLE TO RETRACT THE NEEDLE WITHOUT POTENTIALLY CAUSING HARM ON THE PT. THIS IS THE 3RD CATHETER I HAVE COME ACROSS WITH ISSUE IN THE LAST MONTH, JUST THE FIRST I WAS ABLE TO SAVE TO REPORT. RESPONSE RECEIVED ON 12-SEP-2023: 1. IT WAS MENTIONED THAT THIS HAS HAPPENED FOR THE 3RD TIME. ARE YOU ABLE TO PROVIDE THE DATE OF INCIDENT FOR THE OTHER 2 INCIDENTS? - UNFORTUNATELY, AT THIS TIME I DO NOT KNOW THE OTHER 2 DATES OF INCIDENTS. 2. WAS THE PROCEDURE COMPLETED AS PLANNED? - YES, TO THE BEST OF MY KNOWLEDGE, THEY COMPLETED IT WITH A DIFFERENT CATHETER. 3. PLEASE CONFIRM IF THERE WAS ANY ADVERSE EVENT OR SERIOUS INJURY BEING REPORTED? - NEAR MISS. 4. WAS THERE ANY PATIENT INVOLVEMENT FOR THE PREVIOUS INCIDENT? IF YES, WHAT WAS THE OUTCOME? - UNFORTUNATELY, WE DO NOT KNOW THE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204874 ↗
• MalfunctionNov 24, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT BD NEXIVA NEEDLE WAS DIFFICULT TO DISENGAGE FROM THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION: I ATTEMPTED TO START AN IV ON A PT AND WHEN TRYING TO LOOSEN THE CONNECTIONS ON THE CATHETER, I NOTICED THAT IT WAS SIGNIFICANTLY MORE DIFFICULT THAT IT USUALLY IS. HAD I STARTED THE IV ON THE PT WITHOUT CHECKING. I WOULD HAVE NOT BEEN ABLE TO RETRACT THE NEEDLE WITHOUT POTENTIALLY CAUSING HARM ON THE PT. THIS IS THE 3RD CATHETER I HAVE COME ACROSS WITH ISSUE IN THE LAST MONTH, JUST THE FIRST I WAS ABLE TO SAVE TO REPORT. RESPONSE RECEIVED ON (B)(6) 2023: 1. IT WAS MENTIONED THAT THIS HAS HAPPENED FOR THE 3RD TIME. ARE YOU ABLE TO PROVIDE THE DATE OF INCIDENT FOR THE OTHER 2 INCIDENTS? - UNFORTUNATELY, AT THIS TIME I DO NOT KNOW THE OTHER 2 DATES OF INCIDENTS. 2. WAS THE PROCEDURE COMPLETED AS PLANNED? - YES, TO THE BEST OF MY KNOWLEDGE, THEY COMPLETED IT WITH A DIFFERENT CATHETER. 3. PLEASE CONFIRM IF THERE WAS ANY ADVERSE EVENT OR SERIOUS INJURY BEING REPORTED? - NEAR MISS 4. WAS THERE ANY PATIENT INVOLVEMENT FOR THE PREVIOUS INCIDENT? IF YES, WHAT WAS THE OUTCOME? - UNFORTUNATELY, WE DO NOT KNOW THE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204871 ↗
• MalfunctionAug 29, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM IT WAS LEAKING AT THE HUB. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THERE WAS LEAKING AT THE SITE WHERE THE CATHETER MEETS THE HUB.

  Patient problems: Insufficient Information

  MAUDE report 17647415 ↗
• InjuryAug 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT 3 OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLS HAVE GON THROUGH THE CATHETER. REPORT 3 OF 3. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: OVER THE PAST WEEK THERE HAVE BEEN 3 INSTANCES WHERE THE NEEDLES FOR OUR 1.75 INCH PERIPHERAL IVS HAVE CUT THROUGH THE CATHETERS WHILE INSERTING ULTRASOUND GUIDED IVS. THE PLASTIC CATHETER TIP BROKE OFF AND GOT LODGED IN THE PATIENTS TISSUE. ADDITIONAL INFORMATION RECEIVED ON 09-AUG-2023 THE PRODUCT LOT # WAS 2300204 AND REF # 383518 FOR THE PRODUCT THAT WE KEPT THE SAMPLE OF. THAT IS THE CORRECT BATCH NUMBER. THE PLASTIC CATHETER TIP BROKE OFF AND GOT LODGED IN THE PATIENTS TISSUE. ALL INSTANCES OF THESE CATHETERS BREAKING HAVE HAPPENED WHILE PERFORMING ULTRASOUND GUIDED IVS. ADDITIONAL INFORMATION RECEIVED ON 14-AUG-2023: 1. WHAT WAS THE PATIENT OUTCOME? - REMAINS ON INPATIENT WARD. 2. WAS THE CATHETER TIP ABLE TO BE REMOVED? IF SO, HOW WAS IT RETRIEVED? - THE TIP HAS NOT BEEN REMOVED YET. 3. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT¿S BODY, SUCH AS AN X-RAY? - AN X-RAY WAS DONE AND THE CANNULA WAS NOTED IN THE PATIENT¿S FOREARM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17604884 ↗
• MalfunctionAug 22, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 3 OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLS HAVE GON THROUGH THE CATHETER. REPORT 1 OF 3. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: OVER THE PAST WEEK THERE HAVE BEEN 3 INSTANCES WHERE THE NEEDLES FOR OUR 1.75 INCH PERIPHERAL IVS HAVE CUT THROUGH THE CATHETERS WHILE INSERTING ULTRASOUND GUIDED IVS. WE HAVE A PICTURE OF ONE AND HAVE KEPT A SAMPLE OF ANOTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596672 ↗
• MalfunctionAug 22, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 3 OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLS HAVE GON THROUGH THE CATHETER. REPORT 2 OF 3. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: OVER THE PAST WEEK THERE HAVE BEEN 3 INSTANCES WHERE THE NEEDLES FOR OUR 1.75 INCH PERIPHERAL IVS HAVE CUT THROUGH THE CATHETERS WHILE INSERTING ULTRASOUND GUIDED IVS. WE HAVE A PICTURE OF ONE AND HAVE KEPT A SAMPLE OF ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596431 ↗
• MalfunctionAug 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH BD NEXIVA¿ CLOSED IV CATHETER SYSTEM LEAKAGE OCCURRED AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXIVA IS LEAKING AT THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467056 ↗
• MalfunctionAug 1, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN PLACING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - SINGLE PORT THE CATHETER WAS DISCOVERED TO HAVE HOLES AND BLOOD LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PLACING NEXIVA THE CUSTOMER HAS BLOOD LEAKING OUT OF THE CATHETER WITH VISIBLE HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435801 ↗
• MalfunctionJul 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BD NEXIVA SINGLE PORT, 20G X 1.75" TUBING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED EXTERNAL TUBING SPLIT IN HALF WHILE INJECTING CT CONTRAST (ISOVUE 370) AT A RATE OF 1.9ML/SEC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358102 ↗
• MalfunctionMay 22, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED WHILE USING (BRAND NAME) THE SAFETY FAILED AND THE NEEDLE PIERCED THE SHIELD. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY FAILED; GREY PORTION ATTACHED TO THE SEPTUM SEPARATED FROM THE NEEDLE LEAVING THE SHARP TIP EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979425 ↗
• MalfunctionNov 7, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED WHILE USING BD NEXIVA SINGLE PORT, 20G X 1.75" THE TUBING HAD EXPANDED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MORNING (B)(6) 2022 THE NURSE FOUND THE BD NEXIVA, INSERT AT THE ARM OF THE PATIENT. THE EXTENSION WAS UPBLOWED (DIAMETER OF EXTENSION IN ONE PART LARGER THEN THE NORMAL EXTENSION DIAMETER. SO THE NURSE REMOVED THE BD NEXIVA AND INFORMED THE ADMINISTRATION/SHOPPING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748560 ↗
• MalfunctionOct 13, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.75 IN EXPERIENCED CATHETER SPLITTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT MALFUNCTION OF REF 383518 BARD NEXIVA CLOSED IV CATHETER SYSTEM 20G 1.75 IN 1/1 X 45 MM. USED ULTRASOUND TO ASSIST M PLACEMENT OF PERIPHERAL IV. DURING INSERTION OF IV CATHETER, THE PLASTIC CATHETER SPLIT. PATIENT EXPRESSED FEELINGS OF PAIN AND DISCOMFORT AT THAT TIME. AFTER WITHDRAWING THE IV FROM THE UNSUCCESSFUL IV PLACEMENT ATTEMPT, THIS RN NOTED THAT THE PLASTIC CATHETER SPLIT APART FROM THE NEEDLE DURING INSERTION.

  Patient problems: Pain

  MAUDE report 12628256 ↗
• MalfunctionMar 25, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT NEXIVA 20 GA X 1-3/4 IN SINGLE PORT TUBING EXPANDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383518 BATCH NO.: 0063597 IT WAS REPORTED THAT NEXIVA TUBING EXPANDED SIGNIFICANTLY, BUT DID NOT RUPTURE. PER EMAIL: 1. DATE OF OCCURRENCE: 2/25/21, REPORTED TO ME ON 3/1/21 1. PLACEMENT DATE: (B)(6) 2021 2. EXPLANT DATE: (B)(6) 2021 3. PLACEMENT INFO: UNKNOWN 4. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: TEGADERM 5. A DETAILED DESCRIPTION OF THE EVENT: DEVICE PLACED USING ULTRASOUND FOR AN OUTPATIENT CT. EXCELLENT BLOOD RETURN ON INSERTION. CT RAN AT 325 PSI 4ML/SEC USING OMNIPAQUE 350, CTA OF CHEST/ABDOMEN/PELVIS. SCAN DID NOT COMPLETE AND TUBING ON NEXIVA EXPANDED SIGNIFICANTLY RIGHT BEFORE THE PINK PLATFORM, BUT DID NOT RUPTURE. CT HAS BEEN NOTIFIED THAT NEXIVA IS RATED AT A MAX OF 300 PSI. 6. WAS THERE PATIENT HARM REPORTED?:NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572696 ↗
• MalfunctionAug 25, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT NEXIVA 20 GA X 1-3/4 IN SINGLE PORT HAD INCORRECT LABELING. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. (B)(6). BATCH NO. 9325203 IT WAS REPORTED THAT PACKAGE CONTAINED THE WRONG PRODUCT, INCORRECT LABELING.

  Patient problems: No Patient Involvement

  MAUDE report 10451389 ↗
• MalfunctionNov 14, 2019Break; Break

  MATERIAL NO.: 383518; BATCH NO.: 9150812. IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD THE METAL NEEDLE COME OFF OF THE RETRACTOR GRIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE TRAVELER RNS SAYS THEY WERE USING A 20GA 1.75INCH NEXIVA (LOT 9150812) AND THE METAL NEEDLE CAME OFF OF THE RETRACTOR GRIP. I HAVEN'T HAD AN ISSUE BUT WE DO HAVE A LOT OF THAT LOT IN STOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9323560 ↗
• MalfunctionOct 28, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBING "BLEW" DURING USE AND CONTRAST LEAKED FROM IT. AS A RESULT, THE CT SCAN WAS NOT COMPLETED AND THE PATIENT DID NOT RECEIVE THE FULL CT CONTRAST DOSE. A NEW IV WAS PLACED, BUT A REPEAT CT SCAN WAS "NOT NEEDED". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV TUBING BLEW AND CONTRAST LEAKED. THE RATE AND CONTRAST USED WERE WITHIN THE MANUFACTURER'S GUIDELINE. (ISOVUE 300; 5.5 ML/SEC)" "CT SCAN WAS INCOMPLETE DUE TO THE CONTRAST LEAK. PT. DID NOT RECEIVE FULL CT CONTRAST DOSE. NEW IV PLACED. A REPEAT CT SCAN WAS NOT NEEDED."

  Patient problems: Overdose

  MAUDE report 9244881 ↗
• MalfunctionMar 21, 2019Leak/Splash

  IT WAS REPORTED THAT THERE WERE 2 OCCURRENCES OF CLEAR CAP NOT CONNECTED TO BD NEXIVA¿ 20 GA X 1-3/4 IN SINGLE PORT CAUSING BLOOD LEAKAGE. PER CUSTOMER EMAIL: REPORTED THE FOLLOWING COMPLAINT TO US: ¿WE APPEAR TO HAVE A STOCK OF THE 20G 1.75 NEXIVA CATHETERS (LOT # 9025657) WHERE THE CLEAR CAP AT THE END IS NOT CONNECTED TO THE CATHETER. SO IF YOU DO NOT NOTICE THIS PRIOR TO INSERTION, WHEN YOU PULL BACK THE NEEDLE, BLOOD WILL LEAK OUT OF THE CATHETER. WE HAVE HAD 2 INSTANCES WHERE THIS HAS HAPPENED.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8442073 ↗
• MalfunctionMar 19, 2019Disconnection

  IT WAS REPORTED THAT AFTER USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SINGLE-PORT SYSTEM THE NEXIVA EXTENSION SET DISCONNECTED FROM THE STABILIZATION PLATFORM/HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433432 ↗
• MalfunctionApr 11, 2018Fluid/Blood Leak; Kinked

  IT WAS REPORTED THAT THE  BD NEXIVA¿ CLOSED IV CATHETER SINGLE-PORT SYSTEM HAD A KINK NEAR THE HUB AT THE END OF THE EXTENSION SET PRIOR TO USE. WHEN STARTED, BLOOD LEAKED OUT WHERE THE INITIAL KINK WAS. FOUND DURING USE. EXPSURE TO BLOOD/ BODILY FLUID WAS REPORTED HOWEVER, NO REPORTS OF MEDICAL INTERVENTION OR SERIOUS INJURY WAS NOTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 7422340 ↗