BD Angiocath 381137Recalls & reported problems
Becton, Dickinson And Company · ANGIOCATH PNK 20GA X 1.88IN · Class 2
All models of BD Angiocath (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Angiocath is a short-term intravenous catheter. Many of the 80 reports describe leaking at connectors or tips, contamination such as stains on the needle, and breaks or cracks. The reports include 1 injury and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00382903811373), received between Nov 9, 2017 and Jun 29, 2026 — classified as 1 injury, 79 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (31 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
- Leak/Splash31
- Device Contamination with Chemical or Other Material18
- Break9
- Fluid/Blood Leak9
- Crack4
- Contamination3
- Material Rupture2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Known Impact Or Consequence To Patient22
- No Consequences Or Impact To Patient11
- No Information2
- Foreign Body Embolism1
- Hemorrhage/Blood Loss/Bleeding1
- High Blood Pressure/ Hypertension1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD ANGIOCATH LEAKED. ON (B)(6) 2026, 8:10 A.M.: AN ICU PATIENT RECEIVED AN ART CATHETERIZATION VIA THE RIGHT RADIAL ARTERY. AT 11:20 P.M., BLEEDING WAS OBSERVED AT THE TIP OF THE CATHETER; THE ART CATHETER WAS REPLACED, AND A NEW CATHETERIZATION WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660778 ↗MalfunctionJun 24, 2026Contamination
IT WAS REPORTED THAT BD ANGIOCATH HAD FOREIGN MATTER. WHILE PREPARING TO PERFORM AN INDWELLING NEEDLE PUNCTURE ON A PATIENT ON (B)(6) 2026, THE CANNULA WAS OPENED AND FOUND TO HAVE A STAIN ON THE INDWELLING NEEDLE, WHICH WAS REPLACED AND USED WITHOUT HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25612302 ↗MalfunctionApr 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905187 ↗MalfunctionMar 31, 2026Crack; Leak/Splash; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746204 ↗MalfunctionMar 24, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE ANGIOCATH LEAKED. IN THIS BATCH, FOUR OF THE CATHETERS IN THIS BOX EXHIBITED BLOOD LEAKAGE AT THE CONNECTION BETWEEN THE DRUG ADMINISTRATION PORT AND THE TUBING AFTER USE. THIS ISSUE DID NOT RECUR THEREAFTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675591 ↗MalfunctionMar 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606825 ↗MalfunctionFeb 26, 2026Fluid/Blood Leak; Leak/Splash; Material Rupture
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24458219 ↗MalfunctionJan 30, 2026Fluid/Blood Leak
ON (B)(6) 2026, A SINGLE-USE INTRAVENOUS CATHETER WAS PLACED FOR THE PATIENT TO ADMINISTER INTRAVENOUS FLUIDS. DURING A SUBSEQUENT NURSING ROUND, IT WAS DISCOVERED THAT THE CATHETER NEEDLE WAS LEAKING BLOOD, CAUSING BLOOD LOSS AND STAINING THE BEDDING. THE CATHETER WAS REMOVED. DUE TO THE PATIENT'S ONGOING NEED FOR INTRAVENOUS FLUIDS, A SECOND PUNCTURE WAS PERFORMED TO REINSERT THE CATHETER. THE PATIENT SUBSEQUENTLY RECEIVED INTRAVENOUS FLUIDS WITHOUT FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225570 ↗MalfunctionJan 27, 2026Fluid/Blood Leak; Nonstandard Device
ON (B)(6) 2025, THE PATIENT UNDERWENT ARTERIAL CATHETERIZATION FOR INVASIVE BLOOD PRESSURE MONITORING. ONE DAY AFTER CATHETER PLACEMENT, ON (B)(6), SIGNIFICANT BLEEDING WAS OBSERVED AT THE PUNCTURE SITE. DURING DRESSING CHANGE, A DAMAGED ARTERIAL PUNCTURE NEEDLE WITH BLOOD LEAKAGE WAS DISCOVERED. MEDICAL STAFF IMMEDIATELY REMOVED THE ARTERIAL CATHETER AND APPLIED PRESSURE TO THE SITE, WITH NO ADVERSE CONSEQUENCES. SUBSEQUENTLY, NON-INVASIVE BLOOD PRESSURE MONITORING WAS INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188996 ↗MalfunctionJan 12, 2026Fluid/Blood Leak; Material Rupture
ON (B)(6) 2025, FOLLOWING THE PLACEMENT OF AN ARTERIAL CATHETER, THE OUTER CASING RUPTURED WITHOUT APPARENT CAUSE, LEADING TO ARTERIAL BLOOD LEAKAGE. THIS INCIDENT HAS OCCURRED THREE TIMES WITHIN TWO DAYS. THE NEED FOR A SECOND PUNCTURE HAS INCREASED THE PATIENT'S DISCOMFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24043586 ↗MalfunctionNov 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23640095 ↗MalfunctionNov 19, 2025Leak/Splash; Leak/Splash
(B)(6) 2025, 10:20 AM PATIENT TRANSFERRED FROM GENERAL SURGERY WARD 3 TO ICU. FOR ARTERIAL BLOOD PRESSURE MONITORING AND BLOOD SAMPLING, A RADIAL ARTERY (ART) CATHETER WAS PLACED. AT 3:00 PM, BLOOD LEAKAGE WAS OBSERVED AT THE DISTAL END OF THE ART TUBING. THE ART STRAIGHT TUBE WAS REPLACED, AND NO FURTHER LEAKAGE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23598204 ↗MalfunctionNov 10, 2025Crack; Crack
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23517017 ↗MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23442224 ↗MalfunctionSep 19, 2025Leak/Splash; Leak/Splash
DURING USE, FLUID LEAKAGE OCCURRED AT THE CATHETER CONNECTION POINT. A COMPLAINT RESPONSE LETTER IS REQUIRED, ALONG WITH A COMPLAINT RECEIPT CONFIRMATION. THE DEFECTIVE PRODUCT CANNOT BE RETURNED. VIDEO EVIDENCE IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23101128 ↗MalfunctionJul 5, 2025Packaging Problem; Separation Problem; Packaging Problem; Separation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22407372 ↗MalfunctionJun 25, 2025Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT BD ANGIOCATH CATHETER CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, THE PATIENT WAS GIVEN A PUNCTURE ARTERIAL TUBE PLACEMENT AND FOUND TO HAVE BLOOD OOZING FROM THE PUNCTURE, AND WAS GIVEN FREQUENT DRESSING CHANGES AFTER WHICH BLOOD OOZING STILL EXISTED, AND WAS THEN FOUND TO BE OOZING OUT OF THE INDWELLING NEEDLE HOSE, WHICH WAS REMOVED AND FOUND TO HAVE A CRACK IN THE TUBING, AND THE CATHETER WAS IMMEDIATELY REPLACED, AND INVASIVE BP WAS CONTINUOUSLY MONITORED IN THE RADIAL ARTERY ON THE OTHER SIDE. THE INCIDENT WAS REPORTED TO THE EQUIPMENT DEPARTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22332196 ↗MalfunctionMay 12, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003922 ↗MalfunctionMay 2, 2025Contamination; Contamination
IT WAS REPORTED THAT BD ANGIOCATH FOREIGN MATTER FOUND ON NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, WHILE PREPARING A PATIENT FOR AN ARTERIAL PUNCTURE, THE NURSE UNSEALED THE INDWELLING NEEDLE AND FOUND MULTIPLE BLACK SPOTS IN THE NEEDLE, WHICH WERE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21951227 ↗MalfunctionFeb 10, 2025Device 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 21351482 ↗MalfunctionDec 29, 2024Break; Break
IT WAS REPORTED THAT BD ANGIOCATH CATHETER BROKE DURING RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE TIP OF THE INDWELLING NEEDLE WAS NOT SHARP ENOUGH DURING THE ARTERIAL PUNCTURE, AND THE CANNULA BROKE WHEN THE NEEDLE CENTER WAS RETURNED TO THE SLEEVE. A SECOND PUNCTURE IS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032806 ↗MalfunctionNov 21, 2024Leak/Splash; Leak/Splash
(B)(6) 2024: 2. HAS THE DEVICE BEEN DAMAGED DURING USE? NO DAMAGE 3 . IS THERE ANY IMPACT ON PATIENTS? NO, REPLACE IT WITH A NEW INDWELLING NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20746502 ↗MalfunctionOct 30, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ANGIOCATH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2024, IN THE INTENSIVE CARE UNIT OF (B)(6) HOSPITAL OF (B)(6), THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PYREXIA, AND WAS GIVEN AN ARTERIAL NEEDLE FOR INVASIVE BLOOD PRESSURE MONITORING IN ACCORDANCE WITH THE MEDICAL ADVICE, AND THE NURSE GAVE THE PATIENT A GOOD NEEDLE FOR THE RIGHT BRACHIAL ARTERY, AND THEN CONNECTED THE BLOOD PRESSURE MONITOR, WITH NO ABNORMALITY, AND THEN FOUND THAT THERE WAS A SMALL AMOUNT OF BLOOD OOZING FROM THE ROOT OF THE NEEDLE ON (B)(6) AND THEN CHANGED THE DRESSING OF THE NEEDLE AFTER RE-DISINFECTION OF THE OOZING PART. NO BLOOD SEEPAGE, (B)(6), THE ROOT OF THE INDWELLING NEEDLE AND BLOOD LEAKAGE, TO THE BLOOD SEEPAGE SITE DISINFECTION AND REPLACEMENT OF THE INDWELLING NEEDLE DRESSING, AN HOUR LATER OBSERVATION FOUND THAT THE ROOT OF THE BLOOD SEEPAGE IS OBVIOUS, AND AT THE SAME TIME OOZING LIQUID, CAN NOT CONTINUE TO USE, SO REMOVE THE INDWELLING NEEDLE AFTER REPLACING THE LEFT HAND TO THE PATIENT TO RE-RETAINING THE INDWELLING NEEDLE CAN BE USED NORMALLY, THIS INCIDENT HAS INCREASED THE WORKLOAD OF
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20567904 ↗MalfunctionJul 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD ANGIOCATH LEAKED AT THE CATHETER/HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: (B)(6) 2024 ARTERIAL PUNCTURE AND PLACEMENT OF THE PATIENT BEFORE ANESTHESIA, SUCCESSFUL REMOVAL OF THE GUIDE CORE, BLOOD SEEPAGE FROM THE END OF THE INDWELLING NEEDLE, IMMEDIATE REMOVAL OF THE INDWELLING NEEDLE, REPLACEMENT OF THE INDWELLING NEEDLE AND RE-PUNCTURE NO PATIENT HARM WAS CAUSED BLEEDING AT THE END OF THE INDWELLING NEEDLE SHEATH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19706205 ↗InjuryJun 4, 2024Material Separation; Material Separation
IT WAS REPORTED THAT BD ANGIOCATH CATHETER SEPARATED FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE FIRST LINE OF ANESTHESIA CHECKED THE ARTERIAL CANNULA AFTER REMOVING THE ARTERY AND FOUND THAT THE ARTERIAL CATHETER WAS MISSING AND INCOMPLETE, WHICH WAS IMMEDIATELY REPORTED TO THE SECOND LINE OF ANESTHESIA. ¿THE SECOND-LINE ANESTHESIA TEAM IMMEDIATELY REPORTED IT TO THE CHIEF SURGEON AND DEPARTMENT DIRECTOR, REQUESTING EMERGENCY CONSULTATION FROM THE VASCULAR SURGERY DEPARTMENT AND BEDSIDE ULTRASOUND. ULTRASOUND FOUND FOREIGN BODY RESIDUE IN THE LEFT RADIAL ARTERY. AFTER CONSULTATION, THE VASCULAR SURGERY DEPARTMENT DECIDED TO PERFORM EMERGENCY SURGERY "RADIAL ARTERY FOREIGN BODY REMOVAL". THE SURGEON, ANESTHESIOLOGIST THE DOCTOR AND VASCULAR SURGEON EXPLAINED THE SITUATION AND POSSIBLE CONSEQUENCES TO THE FAMILY MEMBERS. THE FAMILY MEMBERS EXPRESSED THEIR UNDERSTANDING AND AGREED TO THE OPERATION.¿ RADIAL FOREIGN BODY REMOVAL.
Patient problems: Foreign Body Embolism
MAUDE report 19464194 ↗
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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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