BD Insyte-W 381337Recalls & reported problems
Becton, Dickinson And Company · INSYTE-W WINGED PNK 20GA X 1.88IN · Class 2
All models of BD Insyte-W (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903813377), received between Jul 3, 2019 and Oct 15, 2025 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Device Contamination with Chemical or Other Material2
- Defective Device1
- Detachment of Device or Device Component1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Break; Break
THE CATHETER WAS INSERTED INTO THE RADIAL ARTERY PREOPERATIVELY FOR MONITORING PURPOSES ONLY. AT THE END OF THE PROCEDURE, THE CATHETER WAS PULLED OUT. THE STAFF MEMBER PERFORMING THE PROCEDURE NOTICED THAT THE CATHETER WAS SHORTER THAN USUAL. IT WAS THEN DETERMINED SONOGRAPHICALLY THAT A LARGE PART OF THE CATHETER WAS STILL IN THE ARTERY. AN ATTEMPT WAS MADE TO REMOVE IT USING FORCEPS. HOWEVER, AS THIS WAS UNSUCCESSFUL, THE REMAINING PART OF THE CATHETER HAD TO BE SURGICALLY REMOVED FROM THE ARTERY.
Patient problems: Foreign Body In Patient
MAUDE report 23291277 ↗MalfunctionJun 2, 2025Defective Device; Defective Device
IT WAS REPORTED THAT BD INSYTE-W WINGED PNK 20GA X 1.88IN ADAPTER / CONNECTOR DAMAGED / DEFECTIVE THE PATIENT WAS ADMITTED TO THE DEPARTMENT OF CARDIOLOGY ON 20/4 DUE TO CHEST PAIN FOR 3 HOURS AND WAS TRANSFERRED TO THE DEPARTMENT OF INTENSIVE CARE MEDICINE ON 21/4 AT 09:24 DUE TO CRITICAL CONDITION. AT 11:50, THE NURSE PERFORMED INVASIVE ARTERIAL BLOOD PRESSURE PUNCTURE AT THE BEDSIDE, AND WHEN SHE WAS ABOUT TO CONNECT THE CONNECTOR, SHE FOUND THAT THE DISPOSABLE SYRINGE WAS PARTIALLY BROKEN AT THE CONNECTOR AND OOZING BLOOD, AND THEN SHE REPORTED TO THE HEAD NURSE OF THE DEPARTMENT FOR IMMEDIATE REPLACEMENT, AND CLOSELY MONITORED THE BLOOD PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22123700 ↗InjuryJan 28, 2025Break; Break
MalfunctionJul 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD INSYTE-W WINGED PNK 20GA X 1.88IN HAD FOREIGN MATTER. (B)(6) 2024 WHEN MEDICAL STAFF WERE PREPARING TO PERFORM A CESAREAN SECTION ON A PATIENT AND OPENED A DISPOSABLE INTRAVENOUS NEEDLE (WITH A WING SHAPE) TO OPERATE ON THE PATIENT, THEY FOUND THAT THERE WAS A BLACK MARK ON THE NEEDLE BODY AND THE TAIL OF THE NEEDLE WAS YELLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19726549 ↗MalfunctionSep 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WHILE USING THE INSYTE-W WINGED PNK 20GA X 1.88IN, THE CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER INITIALLY APPEARING TO BE KINKED, LINE NOT SUTURED. UPON REPOSITIONING CATHETER AND REMOVING THE SECURING STRIP OVER THE HUB, CATHETER NOTED TO BE COMPLETELY BROKEN OFF AT THE HUB, WITH THE CATHETER STILL IN THE VESSEL (PUSATILE BLOOD FLOW NOTED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15491488 ↗MalfunctionJul 3, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
MATERIAL NO. 381337, BATCH NO. 8265333. IT WAS REPORTED THAT DURING USE OF THE INSYTE-W WINGED PNK 20GA X 1.88IN THE CUSTOMER IS EXPERIENCING ISSUES WITH THE CATHETERS SINCE THE PACKAGING HAS CHANGED, CATHETERS ARE DIFFICULT TO THREAD, SEEM DULL, AND DISLODGE. THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER IS SOMETIMES CHALLENGING TO ADVANCE. THE CATHETERS DISLODGE. THE CATHETERS SEEM DULLER. THESE ISSUES DID NOT SEEM TO OCCUR IN THE SAME DEVICE (SAME CAT #) WITH THE OLD PACKAGING. AS SOON AS PACKAGING CHANGED, ISSUES BEGAN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8761028 ↗
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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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