BD Insyte 381233Recalls & reported problems
Becton, Dickinson And Company · INSYTE PNK 20GA X 1.0IN · Class 2
All models of BD Insyte (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903812332), received between Jun 7, 2019 and Jun 27, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash3
- Break1
- Material Protrusion/Extrusion1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.0IN BLOOD LEAKS OUT OF CONTROL PLUG RUGAO CITY NURSE PLACED AN INDWELLING NEEDLE IN THE PATIENT, AFTER THE GUIDEWIRE WAS PULLED OUT, THE INDWELLING NEEDLE PLUG HAS BEEN LEAKING BLOOD, AFTER THE NURSE REMOVED AND REPLACED THE INDWELLING NEEDLE RE-PUNCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346372 ↗MalfunctionJan 5, 2024Leak/Splash; Leak/Splash
MATERIAL#: 381233 LOT#: 2234335 IT WAS REPORTED BY THE CONSUMER REPORTED THE ISSUE THE CUSTOMER IS HAVING IS THEY ARE LEAKING FROM THE PINK CONNECTOR, AND THIS COULD INCREASE THE RISK OF INFECTION I HAVE ATTACHED OUR PRODUCT COMPLAINT FORM. WE WILL BE CREDITING THE CUSTOMER 7 BOXES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE RECEIVED A COMPLAINT FOR 7 BOXES OF ITEM 333-381233 LOT#2234335 EXP.2027-08-31. THE ISSUE THE CUSTOMER IS HAVING IS THEY ARE LEAKING FROM THE PINK CONNECTOR AND THIS COULD INCREASE THE RISK OF INFECTION I HAVE ATTACHED OUR PRODUCT COMPLAINT FORM. WE WILL BE CREDITING THE CUSTOMER 7 BOXES. PLEASE LET ME KNOW HOW TO PROCEED. OCCURRENCES: RECURRING - CUSTOMER DID NOT RECORD PRODUCT CODE: 381233. PRODUCT DESCRIPTION: CATHETER IV INSYTE 20X1.01IN PINK . LOT/SERIAL #: (B)(6). EXPIRY DATE: 8/31/2027.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18460662 ↗MalfunctionMar 31, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT BD INSYTE¿ IV CATHETERS 20 GAUGE X 1.0" HAD BLOOD EXPOSURE AS WELL AS A NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3 WEEKS AGO CLINICIAN INSERTED INSYTE CANNULA (NON-SAFETY) THEN PUT NEEDLE INSIDE A BLUEY AND THEN PICKED IT UP GETTING A NEEDLE STICK. CLINICIANS ON THE WARD REPORTED THAT THEY HAD NO STOCK OF SAFETY CANNULAS AT THE TIME."
Patient problems: Insufficient Information
MAUDE report 13968317 ↗MalfunctionJan 9, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT INSYTE PNK 20GA X 1.0IN SHEATH SPLIT. THIS OCCURRED ON 50 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381233, BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE SHEATH SPLITS AFTER CATHETER IS INSERTED. COMPLAINT: THE SHEATH THE NEEDLE RESIDES IN UNTIL THE CATHETER IS INSERTED SPLIT. SHE SAID THE TECH DESCRIBED IT AS BEVELING OR FLOWERING OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11143576 ↗MalfunctionNov 12, 2019Retraction Problem; Retraction Problem
IT WAS REPORTED THAT CATHETER HAS BURRS AND IS DIFFICULT TO RETRACT WITH A BD INSYTE¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE COMPANY REPORTER: IT WAS REPORTED THAT THE CATHETER HAS BEEN BURRING AND NOT FUNCTIONING PROPERLY. IT WAS CLARIFIED THAT THE NEEDLE WOULD GIVE RESISTANCE AND CATCH WHEN PULLING IT BACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEALTH PROFESSIONAL NOTED THAT WHEN PULLING THE STYLET BACK BEFORE INSERTION IT IS CREATING RESISTANCE AND CATCHING ON THE HUB PART WHICH MAKES IT NOT FUNCTION PROPERLY. THIS HAS HAPPENED SEVERAL TIMES RECENTLY (NO SPECIFIC DATES COULD BE GIVEN) WITH LOT # 8300598. NO PATIENT OR USER HARM OR MEDICAL INTERVENTION, ONLY ADDITIONAL POKES AND A CHANGE TO A DIFFERENT MANUFACTURER'S CATHETER. SAME ISSUES NOW OCCURRING WITH 22G, COULD NOT PROVIDE PRODUCT INFO. SAMPLES FOR 20G AVAILABLE, ALTHOUGH HE WAS NOT SURE ABOUT 22G. THE TECHNICIANS HAVE HAD A LOT OF ISSUES WITH BURRING AND NOT FUNCTIONING PROPERLY. THEY ACTUALLY HAD TO STOP USING THEM AND SWITCH TO DIFFERENT CATHETERS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9310710 ↗MalfunctionJun 7, 2019Break; Break
IT WAS REPORTED THAT DEFECTIVE CATHETER TIP WAS FOUND WITH A 20G X 1.00IN (1.1 X 25 MM) INSYTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PROBLEM WE WERE ENCOUNTERING IS THAT THE CATHETERS WERE NOT ADVANCING CORRECTLY AND BURRING IN THE PATIENT. WE ATTEMPTED MULTIPLE TIMES AND IT CONTINUED TO HAPPEN, ALL CATHETERS WERE FROM THE SAME LOT. PRODUCTS WERE NOT SAMPLES ISSUED, I ORDER BOXES OF 50 AT A TIME." 1 OF 2 COMPLAINTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8678671 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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