BD Angiocath 382269Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382903822690), received between Oct 30, 2019 and Sep 21, 2023 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2023Break; Break

  NO ADDITIONAL INFORMATION RECEIVED MAT#: 382269 LOT#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT CATHETER BROKE WHILE SUTURED IN TO HORSE. VERBATIM: RCC RECEIVED THE COMPLAINT VIA PHONE. PIR AS ATTACHED. CUSTOMER: XXX FACILITY: XXX ADDRESS: XXX REF 382269 LOT: WILL PROVIDE IN FOLLOW UP ISSUE: CATHETER BROKE WHILE SUTURED IN TO HORSE. TRANSFERRED TO MED INFO CONTACT: 250-851-6760 EMAIL: XXX GOOD AFTERNOON, THANK YOU FOR FOLLOWING UP WITH ME ON THIS SITUATION. I PROVIDED THE LOT NUMBER AND BATCH NUMBER DURING THE INITIAL CALL. THAT WAS ALSO THE DAY OF THE CATHETER BREAKING OFF JUST BELLOW THE SYRINGE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793763 ↗
• InjuryNov 2, 2021Break; Break

  IT WAS REPORTED THAT BD ANGIOCATH SPECIAL ORN 14GA X 5.25IN CATHETER HAD BROKEN OFF INSIDE THE HORSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A BD ANGIOCATH VENOUS CATHETER HAD BEEN IN THE JUGULAR VEIN OF A HORSE SINCE THURSDAY AFTERNOON ((B)(6) 2021). THE VEIN ACCESS WAS LAID BY AN EXPERIENCED VETERINARIAN WITHOUT COMPLICATIONS. IN THE NIGHT FROM SATURDAY, (B)(6) , (B)(6) THE HORSE GOT A LOT WITH A SWOLLEN CATHETER PUNCTURE SITE. THE FASTENING SKIN SUTURE WAS LOOSENED TO REMOVE THE VENOUS CATHETER FROM THE VEIN. MUCH TO THE FACT THAT THIS WAS ONLY ABOUT 1.5CM LONG. THE REST OF THE CATHETER HAD OBVIOUSLY BROKEN OFF. DURING THE ULTRASOUND EXAMINATION, THE REST OF THE CATHETER COULD NO LONGER BE FOUND, THERE IS A SUSPICION THAT IT WAS CARRIED INTO THE RIGHT VENTRICLE OF THE HEART. IS THE PRODUCT IS AVAILABLE FOR EXAMINATION: YES, IT CAN BE PICKED UP AT THE ADDRESS OF THE REPORTING PERSON (HORSE CLINIC AT KOTTENFORST). WERE THERE ANY INJURIES TO THE USER, PATIENT OR THIRD PARTY ?: YES, THE HORSE IS NOW UNUSABLE FOR RIDING DUE TO THE RISK OF THROMBOSIS/PULMONARY EMBOLISM, RESULTING IN AN ALMOST COMPLETE LOSS OF VALUE. ADDITIONAL IMPORTANT INFORMATION: DEATH: NO,

  Patient problems: Foreign Body In Patient

  MAUDE report 12737197 ↗
• MalfunctionSep 9, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ANGIOCATH SPECIAL ORN 14GA X 5.25 IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2021, WHITE PARTICULATES WERE OBSERVED ON THE GLOVE OF CELL THERAPY SPECIALIST CYKH BY REMOVING THE ANGIOCATH FROM THE NEEDLE PROTECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451034 ↗
• MalfunctionSep 9, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ANGIOCATH SPECIAL ORN 14GA X 5.25IN HAD FOREIGN MATTER. THIS OCCURRED ON 7 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARTICLES FOUND IN THE ANGIOCATH PACKAGE. BLACK FIBERS HAVE BEEN OBSERVED IN MANUFACTURING ON THE NEEDLE COVER OF ANGIOCATH. 40 ITEMS WERE INSPECTED OF AND ON 7 ITEMS BLACK FIBERS WERE FOUND. THE BLACK FIBERS WERE ANALYZED USING MICROSCOPIC FOURIER TRANSFORM INFRARED SPECTROSCOPY TECHNIQUE AND SEM/XRMA AT TRISKELION. THE PARTICLES WERE DETERMINED TO BE CELLULOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451028 ↗
• MalfunctionNov 17, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT 14 GA X 5.25 IN EXPERIENCED A CATHETER THAT BROKE/SEPARATED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS TIME WE ARE FAIRLY CERTAIN THE CATHETER HAS BROKEN AND REMAINED IN THE HORSE. THIS TIME IT LOOKS LIKE IT HAS CLEANLY SEPARATED. THE HORSE WAS ADMINISTERED FLUIDS AND MEDICATIONS VIA THE CATHETER AND THERE DOES NOT SEEM TO BE ANY INDICATION THAT THEY WENT SUBCUTANEOUS. WE HAVE KEPT THE CATHETER AND FORTUNATELY HAVE BEEN ABLE TO LOCATE THE PACKET IT WAS IN. WE HAVE PULLED THESE FROM CIRCULATION IN THE (B)(6) HOSPITAL FOR NOW UNTIL WE HAVE A BETTER UNDERSTANDING OF WHAT MAY HAVE HAPPENED.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 10857076 ↗
• InjuryNov 12, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT BROKE OFF FROM THE HUB. AN ULTRASOUND WAS CONDUCTED ON THE HORSE, BUT THE BROKEN PIECE WAS NOT FOUND. THE INFUSION OF MEDICATION WAS FINISHED ORALLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CURRENTLY USE 14G 5.25¿ ANGIOCATH'S AS INTRAVENOUS CATHETERS FOR ELECTIVE SURGERIES ON HORSES. THE CATHETERS ARE PLACED IN THE JUGULAR VEIN OF THE HORSE AND SUTURED IN PLACE. WE THEN PLACE A LIGHT BANDAGE OVER THE CATHETER AROUND THE HORSES NECK. LAST WEEK WE FOUND A PATIENT WITH THE CATHETER HUB AND EXTENSION SET IN PLACE BUT THE CATHETER PORTION BROKEN OFF. THE CATHETER HAD BEEN USED TO ADMINISTER MEDICATIONS ABOUT 1HR PRIOR AND ALL SEEMED TO BE OK. IT IS UNKNOWN IF THE CATHETER REMAINED IN THE HORSE (NOT FOUND ON ULTRASOUND) OR THE CATHETER PULLED OUT AND THEN BROKE. WHEN LOOKING AT THE CATHETER IT LOOKS MORE TORN OR SPLIT THEN SNAPPED. WE HAVE BEEN USING THESE CATHETERS FOR A LONG TIME AND I BELIEVE THIS IS THE FIRST INSTANCE THAT WE HAVE SOMETHING LIKE THIS OCCUR. ULTRASOUND WAS USED TO SEE IF THE CATHETER BROKE IN THE HORSES CHEST BUT NOT VISIBLE. IT COULD HAVE BROKEN EXTERNAL OF THE HORSE IF T

  Patient problems: Foreign Body In Patient

  MAUDE report 10833651 ↗
• InjuryApr 20, 2020Complete Blockage; Leak/Splash; Device Contamination with Chemical or Other Material; Complete Blockage; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ANGIOCATH SPECIAL ORN 14GA X 5.25IN CATHETERS HAVE BEEN BENDING AND BREAKING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382269 BATCH NO: UNKNOWN IT WAS REPORTED THAT THE CATHETERS HAVE BEEN BENDING OR BREAKING DURING MR ABLATION RADIOLOGY PROCEDURES. PER CUSTOMER RESPONSE: WE WERE UTILIZING THE CATHETER AS AN INTRODUCER FOR CRYONEEDLE PLACEMENT IN BOTH SITUATIONS AND ON REMOVAL THE CATHETER FRACTURED. WE HAVE USED THIS CATHETER IN THIS MANNER FOR 11 YEARS WITHOUT PRIOR INCIDENT. IN BOTH CASES THE CATHETER FRACTURED IN THE SUBCUTANEOUS TISSUES NECESSITATING A SMALL INCISION WITH IMAGE GUIDED CATHETER EXTRACTION. IN BOTH CASES NO SIGNIFICANT INJURY RESULTED TO THE PATIENT AND NO CATHETER PARTS WERE LEFT IN THE PATIENT. HOWEVER, GIVEN OUR LONG HISTORY OF USE WITHOUT ISSUE, I WAS CONCERNED THAT SOMETHING IN THE MANUFACTURING PROCESS HAD CHANGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9979770 ↗
• InjuryApr 16, 2020Break; Leak/Splash; Device Contamination with Chemical or Other Material; Break; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED DURING USE THE ANGIOCATH SPECIAL ORN 14 GA X 5.25 IN NEEDLE BROKE/DETACHED, CATHETER BROKE, SEPARATED FROM HUB. MEDICAL ATTENTION REQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES HAVE BEEN BENDING OR BREAKING DURING MR ABLATION RADIOLOGY PROCEDURES. WHILE UTILIZING THE CATHETER AS AN INTRODUCER FOR CRYONEEDLE PLACEMENT IN BOTH SITUATIONS AND ON REMOVAL THE CATHETER FRACTURED. THIS CATHETER HAS BEEN USED IN THIS MANNER FOR 11 YEARS WITHOUT PRIOR INCIDENT. IN BOTH CASES THE CATHETER FRACTURED IN THE SUBCUTANEOUS TISSUES NECESSITATING A SMALL INCISION WITH IMAGE GUIDED CATHETER EXTRACTION. IN BOTH CASES NO SIGNIFICANT INJURY RESULTED TO THE PATIENT AND NO CATHETER PARTS WERE LEFT IN THE PATIENT."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9970182 ↗
• MalfunctionOct 30, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE 14G X 5.25IN (2.1 X 133 MM) ANGIOCATH SPECIAL EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382269, BATCH NO.: 9204248. PER EMAIL: WHILE RECEIVING WE DISCOVERED 1 CS IS MISSING THE LABEL IDENTIFYING THE LOT AND EXPIRATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9257222 ↗