BD Insyte-W 381334Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00382903813346), received between Oct 31, 2018 and Sep 23, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873051 ↗
• MalfunctionSep 8, 2026Leak/Splash; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674224 ↗
• MalfunctionMar 2, 2026Contamination

  RESIDUE, TRACE, IMPURITY, PRESENT ALONG THE CATHETER BEFORE USE DETAILED INCIDENT DESCRIPTION VISIBLE TRACE ALONG THE CATHETER. THE NURSE SAW THE DIRT BEFORE INJECTING THE PATIENT. THE SUSPECT BATCH WAS CHECKED AND THERE IS NO LONGER ANY STOCK IN THE MEDICAL STORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484352 ↗
• MalfunctionSep 26, 2023Material Puncture/Hole; Material Puncture/Hole

  SHORT DESCRIPTION: BEFORE USE - SHIELD ISSUE WHEN DID THE INCIDENT OCCUR? BEFORE USE BEFORE INSERTING THE VENOUS CATHETER, THE NURSE CHECKS THAT THE DEVICE IS WORKING PROPERLY, BY SLIDING THE NEEDLE INTO THE CATHETER: ON RE-INSERTION, THE NEEDLE PUNCTURES THE PLASTIC, RENDERING THE DEVICE UNUSABLE. NO IMPACT PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817970 ↗
• MalfunctionApr 28, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER WHILE INTRODUCING IT INTO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "I WOULD LIKE TO INFORM YOU OF A DEFECT REPORTED BY A NURSE FROM ONE OF OUR ELIVIE PATIENTS. 2 CATHETERS CONCERNED. 1 CATHETER INSYTE AIL. 20G/30MM LOT 2176969. 1 CATHETER INSYTE AIL. 22G/30MM LOT 2209621. WHEN INSERTING THE MANDREL, THE CATHETER DOES NOT FOLLOW. PRESENCE OF A CATHETER PROTRUSION THAT DOES NOT ALLOW INSERTION. NO CONSEQUENCES FOR THE PATIENT. THE IDEL PUT BACK A CATHETER WITH A MODEL THAT SHE HAD IN HER STOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829891 ↗
• MalfunctionMay 5, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE USING BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER A HOLE WAS FOUND IN THE CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER SEEMS TOO LONG AND IS PIERCED BY THE STYLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286165 ↗
• MalfunctionJan 10, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD INSYTE-W¿ IV CATHETER EXPERIENCED THE NEEDLE PIERCING THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE NOTICED THAT WHEN UNLOCKING THE CATHETER AND REMOVING THE MANDREL, THE BODY OF THE CATHETER INSERTED INTO THE PATIENT'S VEIN BENT, RENDERING THE DEVICE UNUSABLE. CLINICAL CONSEQUENCES AND CURRENT STATUS OF THE PATIENT OR AFFECTED PERSON : LOSS OF TIME AND IMPACT ON THE ORGANIZATION OF THE SERVICE. RISK OF PATIENT INJURY ACTIONS TAKEN FOR THE PATIENT OR PERSON INVOLVED LOSS OF TIME AND IMPACT ON THE ORGANIZATION OF THE SERVICE. RISK OF INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13211781 ↗
• MalfunctionFeb 1, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT INSYTE-W WINGED PNK 20GA X 1.16IN CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE END OF THE PATIENT'S INFUSION PLACEMENT, THE NEEDLE OF THE MANDREL REMAINED IN THE CATHETER UNCOUPLED FROM THE PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11263828 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AFTER THE INSYTE-W WINGED PNK 20GA X 1.16IN WAS USED ON THEM FOR A UTERINE CAVITY OPERATION. THE PHYSICIAN WAS CONSULTED, WHO SUGGESTED THE PATIENT WAS EXPERIENCING "SUPERFICIAL VEIN THROMBOSIS". OINTMENT WAS APPLIED, AS WELL AS A HOT COMPRESS TWICE DAILY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: UTERINE CAVITY AFTER OPERATION ON (B)(6) 2020 LINES, RIGHT WRIST DEPARTMENT 2 CM - 3 CM WITH 20 G STRAIGHT NEEDLE IN A VEIN PUNCTURE, SURGERY WITH PROPOFOL, AND CHLORINE XIKANG, RINGO, POSTOPERATIVE WARDS DID NOT USE STIMULANT DRUGS, SURGERY OVER LIEN OUT TWO DAYS LATER, DID NOT INFORM MEDICAL STAFF HAVE ANY DISCOMFORT, (B)(6) PUNCTURE BLOOD VESSELS APPEARED PAIN AND SIDE, DID NOT SEE THE SKIN REDNESS, SKIN TEMPERATURE IS NORMAL, FLAX, AND FEEL TO THE HOSPITAL TO SEE. AND THEY ALSO INVENTED DOCTORS FOR CONSULTATION TENDON, NERVE INTACT, CERVICAL VERTEBRA ORTHOPEDIC CONSULTATION DOES NOT APPEAR PROBLEM, PLEASE THE TWO PHYSICIAN CONSULTATION, IN THE OPERATING ROOM DO B TO EXCEED CHECK, SUGGESTING THE SUPERFICIAL VEIN THROMBOSIS, HELPED HIM OPEN AND COMPLETED OINTMENT, TWICE A DAY OUTS

  Patient problems: Pain

  MAUDE report 10492264 ↗
• MalfunctionAug 3, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE-W¿ IV CATHETERS WITH WINGS 20GA 1.16IN (1.1 X 30 MM) EXPERIENCED THE NEEDLE PIERCING THROUGH THE CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT SEEMS THAT ON SEVERAL OCCASIONS, THE NEEDLE WOULD HAVE PIERCED THE CANNULA AFTER A BACK AND FORTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10360242 ↗
• MalfunctionAug 1, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE-W¿ IV CATHETERS EXPERIENCED THE NEEDLE PIERCING THROUGH THE CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT SEEMS THAT ON SEVERAL OCCASIONS, THE NEEDLE WOULD HAVE PIERCED THE CANNULA AFTER A BACK AND FORTH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10354054 ↗
• MalfunctionMar 11, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER PACKAGING WAS NOT COMPLETELY SEALED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PACKAGING IS OFTEN COMPLETELY SEALED WHICH MAKES IT IMPOSSIBLE TO OPEN IT STERILE. FOR THE TIME BEING, ONLY THIS LOT IS IN STOCK IN THE WAREHOUSE AND IT IS NOT POSSIBLE TO CHECK WHETHER OTHER LOTS ARE INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9819052 ↗
• MalfunctionJan 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE OF THE INSYTE-W WINGED PNK 20GA X 1.16IN PIERCED THE CATHETER PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE CATHETER IS DAMAGED BY THE NEEDLE. THE TUBING THAT IS PIERCED WITH THE NEEDLE BEFORE USE. THE TUBING THAT BENDS IN THE PATIENT'S VEIN DURING THE EXAMINATION CAUSING UNDESIRABLE PRESSURE LIMITS WHEN USING INJECTION PUMPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9644554 ↗
• MalfunctionNov 7, 2019Packaging Problem; Packaging Problem

  IT HAS BEEN REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF OPEN PACKAGING BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IN THE LOCKER, IT WAS FOUND THAT THE PLURALITY OF INDWELLING NEEDLE PACKAGE SEALS HAD BEEN DISENGAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9292753 ↗
• MalfunctionOct 2, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE-W WINGED PNK 20GA X 1.16IN THE NEEDLE WAS TWISTED THROUGH THE CATHETER REQUIRING THE USE OF ANOTHER CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN INTRAVENOUS CATHETERIZATION, THE TIP OF THE MANDREL BEING TWISTED, IT WAS IMPOSSIBLE TO INFUSE THE PATIENT. THE CLINICAL CONSEQUENCES ARE: NONE. HOWEVER, NECESSITY TO USE ANOTHER MEDICAL DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9146157 ↗
• MalfunctionJun 20, 2019Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CATHETER WAS SPLITTING WITH A BD INSYTE-W WINGED PNK 20GA X 1.16IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE PNEUMOLOGY INDICATED TO US TO HAVE ENCOUNTERED A PROBLEM DURING THE USE OF INSYTE-W. FAULT PRESENT: WHEN PLACING A PATIENT'S CATHETER, THE CATHETER WAS PARTIALLY CUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8716139 ↗
• MalfunctionApr 29, 2019Material Protrusion/Extrusion

  IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ IV CATHETER THE NEEDLE WAS THROUGH THE CATHETER BEFORE OPENING THE PACKAGE. THERE WERE SIX OCCURRENCES. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT WAS FOUND NEEDLE THROUGH CATHETER BEFORE OPENING THE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8560601 ↗
• MalfunctionNov 13, 2018Leak/Splash

  IT WAS REPORTED THAT BD INSYTE¿ IV CATHETER LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8066462 ↗
• MalfunctionOct 31, 2018Separation Problem

  IT WAS REPORTED WITH THE USE OF THE BD INSYTE-W¿ IV CATHETER THERE WAS AN ISSUE WITH SEPARATION DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024316 ↗