BD Nexiva 383513Recalls & reported problems
Becton, Dickinson And Company · Nexiva 22 GA X 1.75 IN Single Port · Class 2
All models of BD Nexiva (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382903835133), received between Apr 27, 2020 and Jan 31, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping1
- Improper Flow or Infusion1
- Leak/Splash1
- Material Separation1
- Packaging Problem1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AT LEAST THREE BD NEXIVA 22 GA X 1.75 IN SINGLE PORT LEAKING JUST BEFORE IT CONNECTS TO THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOTICED SEVERAL OF OUR 22-GAUGE BD NEXIVA IV CATHETERS LEAKING JUST BEFORE IT CONNECTS TO THE TUBING. IT IS LEAKING FROM THE IV CATHETER, EVEN BEFORE WE CONNECT IT TO ANYTHING. IT HAPPENS WITH MULTIPLE NURSES, SO I CAN¿T SAY IT¿S A NURSE NOT DOING SOMETHING CORRECTLY. IF WE ARE ONLY INFUSING SALINE, WE CAN JUST PUT A TOWEL UNDERNEATH THE AREA AND INFUSE, BUT THERE IS NO WAY WE WOULD INFUSE CHEMO THROUGH A LEAKING CATHETER, SO WE HAVE TO RESTICK THE PATIENT. WE NOTICE THE LEAK AS SOON AS IT WE PLACE IT AND FLUSH IT. WHEN I FOLLOWED WITH CUSTOMER THEY THINK THEY HAVE SEEN THIS HAPPEN 4-5 TIME IN LAST 3-4 WEEKS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18618309 ↗MalfunctionAug 18, 2023Material Separation; Improper Flow or Infusion; Material Separation; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE USING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM CUSOTMER UNABLE TO FLUSH AND FOUND THE TUBING WAS DEFECTIVE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PIVC WAS INSERTED INTO PT BUT WE WERE UNABLE TO FLUSH THE LINE OR GET ANY BLOOD RETURN. PIVC WAS REMOVED AND NOTED TO HAVE AN AREA INSIDE THE TUBING NEAR THE WINGS THAT IS ACTUALLY NOT CONNECTED TO ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17580664 ↗MalfunctionJul 27, 2023Device Misassembled During Manufacturing /Shipping; Packaging Problem; Device Misassembled During Manufacturing /Shipping; Packaging Problem
IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SHELF PACK HAD A DIFFERENT PRODUCT IN SHELF PACK THAN LISTED. THE FOLLOWING WAS RECEIVED FROM THE INITITAL REPORTER: VERBATIM: SHELF PACK OF 383513 CONTAINS 383538 LOT NO 1147990. CUSTOMER ALSO USES 383538 AND HAPPY TO KEEP STOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17409701 ↗MalfunctionApr 27, 2020Retraction Problem; Retraction Problem
IT WAS REPORTED THAT NEXIVA 22 GA X 1.75 IN SINGLE PORT NEEDLE WOULD NOT RETRACT ALL THE WAY. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383513, BATCH NO.: 8225978. IT WAS REPORTED THAT AFTER INSERTING THE CATHETER INTO THE PATIENT THE NEEDLE WOULD NOT RETRACT ALL THE WAY. THE CATHETER HAD TO BE REMOVED AND A NEW ONE REINSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10002690 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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