BD Angiocath IV Catheter 381134Recalls & reported problems
Becton, Dickinson And Company · ANGIOCATH PNK 20GA X 1.16IN · Class 2
All models of BD Angiocath IV Catheter (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00382903811342), received between Oct 31, 2017 and Jun 9, 2025 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (11 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
- Device Contamination with Chemical or Other Material11
- Leak/Splash2
- Device Appears to Trigger Rejection1
- Labelling, Instructions for Use or Training Problem1
- Material Discolored1
Patient problems
- No Known Impact Or Consequence To Patient6
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
IT WAS REPORTED THAT BD ANGIOCATH LABEL CONTENT IS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, AT XXXX, DURING THE INCOMING INSPECTION OF MATERIAL K-12402-003 LOT 33P25C0178 QTY (B)(4) EA, IT WAS DETECTED MATERIAL WITH DIFFERENT FROM THE GRAPHIC AND THE MASTER SAMPLE. THE SAMPLE CONSISTED OF (B)(4) UNITS, ALL OF WHICH WERE DEFECTIVE. IF (B)(4) UNITS IN THIS SAMPLE ARE DEFECTIVE, THE BATCH IS REJECTED. IT WAS DOCUMENTED A NO CONFORMITY DUE DURING THE INCOMING INSPECTION AT TELEFLEX CHIHUAHUA AN ISSUE RELATED TO ¿INCORRECT PRINTING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22167479 ↗MalfunctionDec 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20858293 ↗MalfunctionSep 3, 2024Leak/Splash; Device Appears to Trigger Rejection; Leak/Splash; Device Appears to Trigger Rejection
IT WAS REPORTED THAT BD ANGIOCATH CATHETER BACKS OUT OF VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SINCE WE HAVE SWITCH REF NUMBER IN THIS PRODUCT, WE HAVE HAD TO CHANGE +++ ARTLINES (IVS IN THE ARTERY) IN THE SAME PATIENT. TYPICALLY, ONE ARTLINE WOULD LAST A PATIENT A STAY IN ICU. IN THE LAST MONTH, WE HAVE BEEN CHANGING MOST OF THEM DAILY. VERY FLIMSY, AS THEY FALL OUT WITH BARELY ANY MOVEMENT. WE HAVE NOT HAD THIS ISSUE IN THE PAST. GREAT PATIENT RISK AS MULTIPLE PUNCTURES ARE REQUIRED, WHICH ARE POTENTIAL INFECTION ISSUES, BRUISING. PATIENT INJURY: NO GOT A RESPONSE FROM THE CUSTOMER ON (B)(6) 2024 PLEASE CLARIFY, IS THE CATHETER FALLING OUT WHILE TAPED IN PLACE? THIS IS CORRECT. TAPED AND SECURED. IS THIS WHAT IS BEING REFERRED TO INDICATING THAT THE A-LINE BEING REPLACED? CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20126145 ↗MalfunctionJun 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ADHERED TO THE BD ANGIOCATH¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT FM ON CATHETER. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, WHEN THE HCP CHECKED THE APPEARANCE OF THE PRODUCT, SOMETHING FLOSSY WAS FOUND TO BE ADHERING TO THE CATHETER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14847160 ↗MalfunctionMay 4, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT ANGIOCATH PNK 20GA X 1.16IN LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED CUSTOMER COMPLAINTS REGARDING THE TWO PRODUCTS BELOW. BOTH CALLS HAVE REPORTED THE SAME ISSUE. 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 11773945 ↗MalfunctionOct 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE ANGIOCATH PNK 20GA X 1.16IN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "381134, BATCH: 7241836, THERE ARE FOREIGN OBJECTS IN THIS PRODUCT."
Patient problems: No Patient Involvement
MAUDE report 10687970 ↗MalfunctionSep 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 2 ANGIOCATH PNK 20GA X 1.16IN CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN CHECKING THE ANGIOCATH BEFORE USE FOR A PATIENT, THE HCP FOUND THAT A LARGE AMOUNT OF A LUBRICANT WAS APPLIED TO THE CATHETER. THE CUSTOMER DID NOT USE THE PRODUCT AND REPORTED TO BD."
Patient problems: No Patient Involvement
MAUDE report 10538642 ↗MalfunctionApr 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED ON CATHETER WITH A BD ANGIOCATH¿ IV CATHETER. THIS OCCURRED ON 3 SEPARATE OCCASIONS PRIOR TO USE WITH BOTH LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE ARE SOME WHITE DROPLET PARTICLES ON THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10012356 ↗MalfunctionJul 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE USE OF THE BD ANGIOCATH¿ IV CATHETER FOREIGN MATTER ADHERES TO THE TIP OF THE CATHETER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: FM ON THE CATHETER TIP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8772147 ↗MalfunctionOct 17, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WATER DROP-LIKE FOREIGN MATTER WAS FOUND ON THE BD ANGIOCATH¿ IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7975013 ↗MalfunctionAug 17, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE USE A BD ANGIOCATH¿ IV CATHETER WAS FOUND WITH FOREIGN MATTER AS ¿SWOLLEN CATHETER.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7793764 ↗MalfunctionMar 23, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE USE A BD ANGIOCATH¿ IV CATHETER WAS FOUND WITH FOREIGN MATTER AS ¿THE CATHETER HAS A FRINGE CLOSE TO THE TIP.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7366934 ↗MalfunctionMar 19, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS ON THE CATHETER OF A BD ANGIOCATH¿ IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7351107 ↗MalfunctionJan 4, 2018Material Discolored
IT WAS REPORTED THAT THE CATHETER ON A BD ANGIOCATH¿ IV CATHETER WAS DISCOLORED TO BLACK BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.
Patient problems: No Patient Involvement
MAUDE report 7164227 ↗MalfunctionOct 31, 2017Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER (PARTICLE) WAS FOUND ON THE CATHETER OF THE BD ANGIOCATH¿ IV CATHETER 20G X 1.16 IN, BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6992058 ↗
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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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