BD Nexiva, BD Q-Syte 383537Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 20GA 1.25IN HF Y · Class 2
All models of BD Nexiva, BD Q-Syte (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nexiva intravenous catheter is a short-term tube placed in a vein. Of its 165 adverse event reports, 160 are malfunctions, mainly describing fluid or blood leaking from the port or tubing, and some describing parts coming apart. The reports also mention 5 injuries and no deaths. One report describes a staff member splashed in the eyes with blood-stained contrast fluid. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 161
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 00382903835379), received between Oct 27, 2017 and Jun 18, 2026 — classified as 5 injuries, 156 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (65 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash65
- Material Separation15
- Break12
- Fluid/Blood Leak12
- Detachment of Device or Device Component8
- Difficult or Delayed Activation7
- Crack6
- Device Contamination with Chemical or Other Material6
Patient problems
- No Clinical Signs, Symptoms or Conditions78
- No Known Impact Or Consequence To Patient53
- No Consequences Or Impact To Patient7
- Exposure to Body Fluids6
- Insufficient Information4
- Foreign Body In Patient3
- No Information3
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Leak/Splash
NURSE EDUCATOR ON ROUND OBSERVED THAT 20 G NEXIVA IS LEAKING FROM Y-PORT IN A CHEMOTHERAPY WARD WHILE FLUSHING POSSIBLY DUE TO MECHANICAL ERROR OR FAULTY CANNULA. AFTER INSERTING ANOTHER CANNULA, NO SUCH INCIDENCE RECORDED. SAFETY ISSUE: AS THE INCIDENT HAPPENED IN CHEMO WARD, THIS COULD HAPPEN WHILE ADMINISTERING THE HIGHLY VESICANT CHEMO DRUGS AND NOT JUST FLUSH. HOWEVER, THE EVENT WAS NOT FATAL, BUT SURELY A NEAR MISS AS IT CAME IN THE EYES OF MANAGEMENT AS WELL AS CLINICIANS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25552920 ↗MalfunctionApr 23, 2026Leak/Splash
IT WAS REPORTED THAT A STAFF MEMBER WAS SPRAYED IN EYES DURING A CONTRAST INJECTION. A NEXIVA DUAL PORT WITH 1 TUTA HPORT CONNECTOR AND 1 Q-STYLE CONNECTOR WAS BEING USED IN CT FOR A CONTRAST INJECTION. THE CONTRAST INJECTION WAS GIVEN THROUGH THE PRESSURE INJECTABLE HPORT AND BLOOD STAINED CONTRAST THEN SPRAYED OUT THE NON-PRESSURE INJECTABLE Q-STYLE CONNECTOR. UNFORTUNATELY THIS WAS WHEN A RADIOGRAPHER WAS CHECKING THE SITE DURING INJECTION AND WAS SPRAYED IN THE EYES. EXPOSURE TO BLOOD/BODILY FLUIDS. STAFF MEMBER RECEIVED BLOOD EXPOSURE TO EYES. HOSPITAL POLICY FOLLOWED POST EXPOSURE. (B)(6) 2026 - RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT FOR INFORMATION COULD YOU PLEASE PROVIDE INFORMATION RELATED TO THE TYPE OF CARE RECEIVED BY THE HEALTHCARE WORKER TO INCLUDE ANY DIAGNOSTICS AND MEDICAL TREATMENT REQUIRED. FROM THE CUSTOMER IN ORIGINAL PIR ¿STAFF MEMBER RECEIVED BLOOD EXPOSURE TO EYES. HOSPITAL POLICY FOLLOWED POST EXPOSURE¿ NO FURTHER INFORMATION AVAILABLE.
Patient problems: Exposure to Body Fluids
MAUDE report 24974424 ↗MalfunctionApr 11, 2026Leak/Splash; Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852485 ↗MalfunctionApr 6, 2026Leak/Splash; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794524 ↗MalfunctionMar 25, 2026Leak/Splash
IT WAS REPORTED THAT A NEXIVA LEAKED. DESCRIPTION OF COMPLAINT. AFTER INSERTING THE INFUSION NEEDLE INTO THE VEIN, BLOOD DRIPPED FROM THE PIECE OF TUBING BETWEEN THE CLIP AND THE TWO CONNECTORS. DUE TO LEAKAGE FROM THE DRIP, THIS HAD TO BE REMOVED AND PATIENT WAS RE-PUNCTURED TO PLACE AN INFUSION. DATE WHEN THE COMPLAINT OCCURRED: 8 MARCH 2026. THE COMPLAINT WAS OBSERVED DURING COMMISSIONING OF THE PRODUCT; THIS AFFECTED THE PATIENT. ADDITIONAL INFORMATION 3/25/2026: OTHER THEN HAVING TO REPLACE THE IV, WAS THERE ANY HARM/SERIOUS INJURY TO THE PATIENT DIRECTLY RELATED TO THIS EVENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689488 ↗MalfunctionMar 6, 2026Leak/Splash; Material Puncture/Hole
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24533762 ↗MalfunctionMar 4, 2026Leak/Splash
THE PLUGS LOCATED AT THE EXTENSION ARE NOT PROPERLY SCREWED IN FOLLOWING MANUFACTURING, SO THAT DURING IRRIGATION AFTER INSTALLATION, THE SECOND PLUG IS EXPELLED = BLOOD FLOW, CONTAMINATION OF THE PLUG, AND POSSIBLY THE NEXIVA DEVICE, WHICH THEN REQUIRES REMOVAL AND INSTALLATION OF A NEW ONE. EVENTS HAVE ALSO BEEN REPORTED DURING IRRIGATION AFTER IV MEDICATION ADMINISTRATION = BLOOD SPLASHING ONTO THE HEALTHCARE PROVIDER. ADDITIONAL INFORMATION: THE CAPS ON THE EXTENSION TUBING ARE NOT PROPERLY SCREWED ON DURING MANUFACTURING, SO THAT DURING IRRIGATION AFTER INSERTION, THE SECOND CAP IS EJECTED, RESULTING IN BLOOD FLOW, CONTAMINATION OF THE CAP AND POSSIBLY THE NEXIVA DEVICE, REQUIRING REMOVAL AND REPLACEMENT. INCIDENTS HAVE ALSO BEEN REPORTED DURING IRRIGATION FOLLOWING IV MEDICATION ADMINISTRATION, SUCH AS BLOOD SPLASHING ON THE HEALTHCARE PROVIDER. PATIENT INJURY UNCONFIRMED. COMPLAINT NOTICED: DURING / AFTER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507246 ↗MalfunctionMar 4, 2026Leak/Splash
THE PLUGS LOCATED AT THE EXTENSION ARE NOT PROPERLY SCREWED IN FOLLOWING MANUFACTURING, SO THAT DURING IRRIGATION AFTER INSTALLATION, THE SECOND PLUG IS EXPELLED = BLOOD FLOW, CONTAMINATION OF THE PLUG, AND POSSIBLY THE NEXIVA DEVICE, WHICH THEN REQUIRES REMOVAL AND INSTALLATION OF A NEW ONE. EVENTS HAVE ALSO BEEN REPORTED DURING IRRIGATION AFTER IV MEDICATION ADMINISTRATION = BLOOD SPLASHING ONTO THE HEALTHCARE PROVIDER. ADDITIONAL INFORMATION: THE CAPS ON THE EXTENSION TUBING ARE NOT PROPERLY SCREWED ON DURING MANUFACTURING, SO THAT DURING IRRIGATION AFTER INSERTION, THE SECOND CAP IS EJECTED, RESULTING IN BLOOD FLOW, CONTAMINATION OF THE CAP AND POSSIBLY THE NEXIVA DEVICE, REQUIRING REMOVAL AND REPLACEMENT. INCIDENTS HAVE ALSO BEEN REPORTED DURING IRRIGATION FOLLOWING IV MEDICATION ADMINISTRATION, SUCH AS BLOOD SPLASHING ON THE HEALTHCARE PROVIDER. PATIENT INJURY UNCONFIRMED. COMPLAINT NOTICED: DURING / AFTER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507230 ↗MalfunctionJan 21, 2026Crack; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24134206 ↗MalfunctionJan 20, 2026Material Integrity Problem
MATERIAL NUMBER PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24124173 ↗MalfunctionNov 25, 2025Material Integrity Problem; Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23652530 ↗MalfunctionNov 5, 2025Material Integrity Problem; Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476631 ↗MalfunctionJun 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 20GA 1.25IN LEAKED. DURING INSERTION OF THE BD NEXIVA IV CATHETER POST REMOVAL OF STYLET, THERE WAS LEAKAGE OF THE BLOOD FROM THE CATHETER HUB SITE (POINT FROM THE STYLET IS TAKEN OUT). AS POST REMOVAL OF THE STYLET, IT SHOULD BE AUTOMATIC SEALED THROUGH ITS CLOSED VALUE, BUT DUE TO SOME MALFUNCTION THE BLOOD LEAKED FROM THAT SIDE. ISSUE: BLOOD LEAKAGE OBSERVED FROM THE CATHETER HUB UPON REMOVAL OF THE STYLET EXPECTED OUTCOME: THE CATHETER HUB SHOULD AUTO-SEAL POST STYLET REMOVAL ACTUAL OUTCOME: BLOOD LEAKAGE OCCURRED POTENTIAL BLOOD EXPOSURE TO THE PATIENT REQUIRED CANNULA RE-SITING CURRENT STATUS: THE ER TEAM AT XXXXX IS UTILIZING NEXIVA, AND THIS ISSUE HAS RAISED CONCERNS REGARDING PATIENT SAFETY AND PROCEDURAL EFFICIENCY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22304547 ↗MalfunctionJun 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 20GA 1.25IN LEAKED AT THE TIME OF CATHETER INSERTION, WHEN NURSING STAFF PULLED THE STYLET OUT AND NOTICE BLOOD SPLASHING AT THE SEPTUM. THE LEAKING IS OCCURRING AT THE HUB WHERE THE NEEDLE IS EXTRACTED. ATTACHED THE PHOTOGRAPH OF SAME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22213506 ↗MalfunctionMay 5, 2025Crack; Crack
EVENT DETAILS: MATERIAL # 383537. BATCH #4212093, 4156923. IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT CRACKED AT HUB. STARTED THE IV AND THEN IT LEAKED EVERYWHERE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DATE OF INCIDENT: (B)(6) 2025. DEPARTMENT: OPERATING ROOM. PRODUCT: BD NEXIVA 20 G. VMID: (B)(4). LOT NUMBER: 4212093, 4156923. PRODUCT EXPIRY DATE: 31-MAY-2027. NUMBER OF DEFECTIVE PRODUCT(S): (B)(4). IS SAMPLE AVAILABLE: YES. CONCERN DESCRIPTION: CRACKED AT HUB. STARTED THE IV AND THEN IT LEAKED EVERYWHERE AND PT HAD TO GET STABBED TWICE!
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21964939 ↗MalfunctionMay 5, 2025Crack; Crack
EVENT DETAILS: MATERIAL # 383537, BATCH #4212093, 4156923. IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT CRACKED AT HUB. STARTED THE IV AND THEN IT LEAKED EVERYWHERE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DATE OF INCIDENT: (B)(6) 2025. DEPARTMENT: OR. PRODUCT: BD NEXIVA 20 G. VMID: 383537. LOT NUMBER: 4212093, 4156923. PRODUCT EXPIRY DATE: 31-MAY-2027. NUMBER OF DEFECTIVE PRODUCT(S): 1. IS SAMPLE AVAILABLE: YES. CONCERN DESCRIPTION: CRACKED AT HUB. STARTED THE IV AND THEN IT LEAKED EVERYWHERE AND PT HAD TO GET STABBED TWICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21964763 ↗InjuryApr 25, 2025Break; Material Integrity Problem; Break; Material Integrity Problem
MalfunctionApr 21, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21875694 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT BD NEXIVA HAD A BROKEN HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE HAD A BROKEN HUB. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21875693 ↗MalfunctionApr 17, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859584 ↗MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21323311 ↗MalfunctionFeb 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA LEAKED AT THE SEPTUM WHEN THE NEEDLE WAS REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER REMOVING THE STELLATE THEY EXPERIENCE THE BLOOD LEAKAGE FROM SELF SEALING SEPTUM HUB OF NEXIVA IN 4 CASES. I COULDN'T COLLECT THE EFFECTED SAMPLE BUT I HAVE COLLECTED SAME BATCH NEW SAMPLE. THE GOOD VAIN HAS DAMAGES REPORTED BY NURSE.
Patient problems: Perforation of Vessels
MAUDE report 21317693 ↗MalfunctionJan 29, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21270195 ↗MalfunctionJan 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 20GA 1.25IN HF Y LEAKED. THE SEPTUM OF THE BD NEXIVA DP 20G 383537, THROUGH WHICH THE SAFETY CANNULA IS REMOVED, LEAKS DURING SUBSEQUENT USE. WHEN DID THE INCIDENT OCCUR? DURING USE. DETAILED INCIDENT DESCRIPTION: THE SEPTUM OF THE BD NEXIVA DP 20G 383537, THROUGH WHICH THE SAFETY CANNULA IS REMOVED, LEAKS DURING SUBSEQUENT USE. BOTH BLOOD AND INFUSION SOLUTION COME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21183522 ↗MalfunctionJan 8, 2025Leak/Splash; Leak/Splash
DESCRIPTION OF COMPLAINT: THE ¿RUBBER SEALING POINT,¿ WHERE THE NEEDLE IS PULLED OUT, DOES NOT SEAL PROPERLY AFTER NEEDLE REMOVAL. BLOOD CAME OUT AFTER INFUSION AND AIR WAS ALSO SUCKED IN WHEN BLOOD WAS DRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102434 ↗
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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.
How reports and recalls are matched · Editorial policy · Report an error on this page