BD Angiocath IV Catheter 381123Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00382903811236), received between Oct 31, 2017 and May 21, 2026 — classified as 2 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (35 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 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. "IT WAS REPORTED THAT DURING PERIPHERAL IV CANNULATION WITH THE ANGIOCATH, FLASHBACK WAS OBTAINED CONFIRMING VENOUS ACCESS. UPON PARTIAL WITHDRAWAL OF THE NEEDLE AND ADVANCEMENT OF THE CATHETER INTO THE VEIN, THE NEED TIP APPEARED DISTORTED (SEE IMAGE ATTACHED), WITH SEPARATION AT THE DISTAL NEEDLE TIP." RESPONSE RECEIVED ON: 5/7/2026 WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN. THE PATIENTS WERE NOT HARMED; HOWEVER, THEY EXPERIENCED PAIN DURING IV CATHETER INSERTION AND THROUGHOUT THE TIME THE CATHETER REMAINED IN THE VEIN. IT IS STATED THAT "SIMILAR OCCURRENCES HAVE BEEN NOTICED ON MULTIPLE OCCASIONS WITH DIFFERENT NURSES" HAVE THESE PAST EVENTS BEEN REPORTED TO BD (IF SO, COULD YOU REFERENCE ANY RECORD NUMBERS). IF THESE EVENTS HAVE NOT BEEN REPORTED, COULD YOU PROVIDE ANY ADDITIONAL DETAILS FOR THESE EVENTS? ALL EVENTS WERE REPORTED TOGETHER IN A SINGLE COMMUNICATION, ALTHOUGH THEY LIKELY INVOLVED DIFFERENT NURSES AT DIFFERENT TIMES.

  Patient problems: Pain

  MAUDE report 25243472 ↗
• MalfunctionMay 14, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. "IT WAS REPORTED THAT DURING PERIPHERAL IV CANNULATION WITH THE ANGIOCATH, FLASHBACK WAS OBTAINED CONFIRMING VENOUS ACCESS. UPON PARTIAL WITHDRAWAL OF THE NEEDLE AND ADVANCEMENT OF THE CATHETER INTO THE VEIN, THE NEED TIP APPEARED DISTORTED (SEE IMAGE ATTACHED), WITH SEPARATION AT THE DISTAL NEEDLE TIP." RESPONSE RECEIVED ON: (B)(6) 2026 WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN. == THE PATIENTS WERE NOT HARMED; HOWEVER, THEY EXPERIENCED PAIN DURING IV CATHETER INSERTION AND THROUGHOUT THE TIME THE CATHETER REMAINED IN THE VEIN. IT IS STATED THAT "SIMILAR OCCURRENCES HAVE BEEN NOTICED ON MULTIPLE OCCASIONS WITH DIFFERENT NURSES" - HAVE THESE PAST EVENTS BEEN REPORTED TO BD (IF SO, COULD YOU REFERENCE ANY RECORD NUMBERS). IF THESE EVENTS HAVE NOT BEEN REPORTED, COULD YOU PROVIDE ANY ADDITIONAL DETAILS FOR THESE EVENTS? == ALL EVENTS WERE REPORTED TOGETHER IN A SINGLE COMMUNICATION, ALTHOUGH THEY LIKELY INVOLVED DIFFERENT NURSES AT DIFFERENT TIMES.

  Patient problems: Pain

  MAUDE report 25175343 ↗
• MalfunctionMay 14, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE NEEDLE PIERCED THE CATHETER. "IT WAS REPORTED THAT DURING PERIPHERAL IV CANNULATION WITH THE ANGIOCATH, FLASHBACK WAS OBTAINED CONFIRMING VENOUS ACCESS. UPON PARTIAL WITHDRAWAL OF THE NEEDLE AND ADVANCEMENT OF THE CATHETER INTO THE VEIN, THE NEED TIP APPEARED DISTORTED (SEE IMAGE ATTACHED), WITH SEPARATION AT THE DISTAL NEEDLE TIP." RESPONSE RECEIVED ON: 5/7/2026 WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN. THE PATIENTS WERE NOT HARMED; HOWEVER, THEY EXPERIENCED PAIN DURING IV CATHETER INSERTION AND THROUGHOUT THE TIME THE CATHETER REMAINED IN THE VEIN. IT IS STATED THAT "SIMILAR OCCURRENCES HAVE BEEN NOTICED ON MULTIPLE OCCASIONS WITH DIFFERENT NURSES" - HAVE THESE PAST EVENTS BEEN REPORTED TO BD (IF SO, COULD YOU REFERENCE ANY RECORD NUMBERS). IF THESE EVENTS HAVE NOT BEEN REPORTED, COULD YOU PROVIDE ANY ADDITIONAL DETAILS FOR THESE EVENTS? ALL EVENTS WERE REPORTED TOGETHER IN A SINGLE COMMUNICATION, ALTHOUGH THEY LIKELY INVOLVED DIFFERENT NURSES AT DIFFERENT TIMES.

  Patient problems: Pain

  MAUDE report 25175332 ↗
• MalfunctionApr 27, 2026Leak/Splash; Premature Separation

  IT WAS REPORTED THAT THE ANGIOCATH LEAKED. DURING THE PUNCTURE THAT A CAP WAS NOT ATTACHED TO STOP THE BLOOD, AND THE PROCEDURE WAS INTERRUPTED DUE TO THE RISK OF CONTAMINATION DUE TO BACKFLOW OF BLOOD TO THE HAND DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999151 ↗
• MalfunctionApr 7, 2026Contamination

  IT WAS REPORTED THAT FOUND BLACK COLORATION AROUND THE MANTLE AND EDGES BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801784 ↗
• MalfunctionNov 25, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23652589 ↗
• InjuryMar 10, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21562518 ↗
• MalfunctionFeb 19, 2025Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411901 ↗
• MalfunctionMay 14, 2024Break; Break

  (B)(6)2024: COULD YOU CONFIRM WHETHER THERE HAVE BEEN NEGATIVE CONSEQUENCES FOR THE PATIENT? (SERIOUS INJURIES, MEDICAL INTERVENTION, NEED TO CHANGE TREATMENT)? NO, NO CONSEQUENCES PLEASE PROVIDE AN EVENT DATE: (B)(6)2024. HAS THERE BEEN AN EXPOSURE OF HEALTH CARE PERSONNEL TO BLOOD OR BODY FLUIDS? NO. HAVE ANY OTHER ACTIONS BEEN TAKEN? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311330 ↗
• InjuryMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD ANGIOCATH CATHETER SEPARATED OR BROKE; RETAINED OBJECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A SERIOUS INCIDENT THAT OCCURRED WITH A PATIENT, WHERE THE PLASTIC PART OF THE IV CANNULA WAS RETAINED IN THE PATIENT¿S VEIN AFTER REMOVING HER IV LINE. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2024 AT 5:20PM, COMPLAINING FROM PERSISTENT BLEEDING FROM THE SITE OF THE IV INSERTION SHE HAD THAT SAME DAY AT CMC; LEFT HAND FOREIGN BODY WAS SUSPECTED, CONFIRMED AND REMOVED BY A SURGEON. MOST PROBABLY THAT THE CANNULA WAS DETACHED FROM THE BLUE TIP OF THE ANGIOCATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 19308975 ↗
• MalfunctionDec 11, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ANGIOCATH LEAKED AT THE CATHETER JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2023, PATIENT UNDERWENT FEMORAL HEAD SURFACE REPLACEMENT IN THE OPERATING ROOM OF OUR HOSPITAL. AFTER THE ANESTHESIOLOGIST PLACED THE PATIENT'S TUBE, HE FOUND THAT THE PATIENT'S INDWELLING NEEDLE HAD AN OBVIOUS HEMATOMA IN THE PATIENT'S BODY NEAR THE END OF THE NEEDLE. THE ANESTHESIOLOGIST WITHDREW THE NEEDLE AND REPLACED IT WITH A NEW ONE, WHICH WAS THEN USED NORMALLY WITHOUT ANY ADVERSE EFFECTS. THE ANESTHESIOLOGIST EXAMINED THE DEFECTIVE DEVICE POSTOPERATIVELY, AND WHEN HE ADMINISTERED THE FLUID TO THE DEFECTIVE DEVICE, HE FOUND THAT THE FLUID WAS SPILLING OUT OF THE BACK OF THE NEEDLE, WHICH MEANT THAT THERE WAS A BREAK IN THE NEEDLE NEAR THE END OF THE INDWELLING NEEDLE, BUT THE DEVICE WAS TOO SMALL TO BE PHOTOGRAPHED CLEARLY. THE SITUATION WAS SO URGENT DURING THE PROCEDURE THAT THE PHYSICIAN DID NOT TAKE A PICTURE OF THE PATIENT AT THE TIME OF THE ADVERSE EVENT. (THERE IS NOTHING WRONG WITH THE ATTACHED PICTURE, THE SYRINGE IS FOR TESTING THE LEAKAGE OF THE INDWELLING NEEDLE, THE BLUE CONNECTOR AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307539 ↗
• MalfunctionAug 11, 2023Defective Component; Defective Component

  NO ADDITIONAL INFORMATION RECEIVED THIS IS A REPORT ABOUT A DAMAGED CATHETER TIP. THE CATHETER TIP WAS JAGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17507459 ↗
• MalfunctionJun 19, 2023Break; Break

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152841 ↗
• MalfunctionNov 9, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER SILICONE WAS VISIBLE ON THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS POTENTIALLY ANY EXCESS SILICONE PRESENT IN THAT LOT OR IF THERE HAD BEEN A CHANGE IN SILICONE USED IN THE LOT. WAS LOT 1168743 WAS AN ABERRANT BATCH OR NOT E.G. EXCESS SILICONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759803 ↗
• MalfunctionOct 31, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER THERE WAS VISIBLE SILICONE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS POTENTIALLY ANY EXCESS SILICONE PRESENT IN THAT LOT OR IF THERE HAD BEEN A CHANGE IN SILICONE USED IN THE LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15704309 ↗
• MalfunctionAug 30, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER EXPERIENCED CATHETER DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DEFORMED CATHETER OF ANGIOCATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324359 ↗
• MalfunctionAug 22, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THREE BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER PACKAGE SEAL UNIT WAS OPENED WHERE STERILITY OF THE PRODUCT IS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT OPEN PACKAGES OF ANGIOCATH. ACCORDING TO THE CUSTOMER'S REPORT, SEVERAL PACKAGES WERE FOUND TO BE ALREADY OPEN BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272018 ↗
• MalfunctionAug 9, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE USING BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER THE NEEDLE PIERCED THE CATHETER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT NEEDLE THROUGH CATHETER. ACCORDING TO THE CUSTOMER'S REPORT, WHEN CHECKING THE PRODUCT BEFORE USE, THE HCP FOUND THAT THE NEEDLE WAS PIERCING THROUGH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191455 ↗
• MalfunctionJun 22, 2022Material Separation; Material Separation

  IT WAS REPORTED WHEN THAT BEFORE USE OF THE BD ANGIOCATH¿ IV CATHETER THE NEEDLE AND THE CATHETER WERE SEPARATED FROM THE HUB AND TRAPPED INSIDE THE NEEDLE COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. WHEN THE HCP REMOVED THE PROTECTION NEEDLE COVER BEFORE USE, THE NEEDLE AND THE CATHETER WERE SEPARATED FROM THE HUB AND TRAPPED INSIDE THE NEEDLE COVER.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14773285 ↗
• MalfunctionNov 15, 2021Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD ANGIOCATH¿ IV CATHETER THE CATHETER KINKED/BENT DURING INFUSION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER VENIPUNCTURE, ADMINISTRATION OF THE NUTRIENT FLUID WAS STARTED, THEN LEAKAGE WAS OBSERVED; WHEN REMOVING THE CATHETER AND CHECKING IT, THE HCP FOUND THAT THE CATHETER WAS BENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816729 ↗
• MalfunctionOct 15, 2021Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT ANGIOCATH BL 22GA X 1.0IN HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT AIR IN LINE WITH THE USE OF ANGIOCATH. ACCORDING TO THE CUSTOMER'S REPORT, WHEN CONNECTING TO THE A LINE, AIR ENTERED. THE CUSTOMER IS SUSPECTING THAT THERE MAY BE A CRACK ON THE CATHETER OR THE CATHETER HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12640273 ↗
• MalfunctionAug 6, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT ANGIOCATH BL 22GA X 1.0IN BLOOD CONTROL FEATURE WAS NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY HAVE SAID THAT WHEN THE CATHETER IS IN THE ANIMAL THEY FIND IT HARD TO GET THE BUNG THAT STOPS THE BLOOD TO STAY IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286153 ↗
• MalfunctionJun 17, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT 2 BD ANGIOCATH¿ IV CATHETERS' NEEDLES WERE DIFFICULT TO RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "IT IS DIFFICULT TO WITHDRAW THE NEEDLE CORE DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021722 ↗
• MalfunctionMay 4, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ONCE INSERTED INTO THE PATIENT, THE BD ANGIOCATH¿ IV CATHETER LEAKED IV FLUID/BLOOD. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONCE INSERTED INTO THE PATIENT AND BUNGED, THE CATHETER WILL EITHER LEAK IV FLUID OR BLOOD FROM THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773944 ↗
• MalfunctionApr 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ANGIOCATH¿ IV CATHETER LEAKED FROM THE TUBE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE CUSTOMER REPORTED ABOUT LEAKAGE OCCURRING FROM THE ROOT OF THE CATHETER SHEATH (CATHETER TUBE).".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728728 ↗