BD A-Line™ Arterial Blood Collection Syringe 364356Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 50382903643566), received between Mar 14, 2024 and Jul 17, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT WHEN USING THE BD A-LINE¿, THE PLUNGER BROKE ON 386 UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535758 ↗
• MalfunctionJul 17, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT WHEN USING THE BD A-LINE¿, THE PLUNGER BROKE ON 443 UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535750 ↗
• MalfunctionJun 18, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BEFORE USING ONE (1) BD A-LINE¿, THE SCALE PRINTING ON THE SYRINGE IS MISALIGNED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284680 ↗
• MalfunctionMay 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BEFORE USING THE BD A-LINE¿, THERE WAS NO LABEL ON ONE (1) SHIPPING CARTON. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044620 ↗
• MalfunctionMay 7, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BEFORE USING ONE (1) BD A-LINE¿, POOR SCALE PRINTING WAS OBSERVED ON THE SYRINGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977486 ↗
• MalfunctionFeb 25, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BEFORE USING THE BD A-LINE¿, TWO BOXES WERE MISSING THE PRODUCT LABEL. THE SPECIFIC LABELS THAT ARE REPORTED MISSING ARE UNKNOWN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459260 ↗
• MalfunctionJan 9, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED PRIOR TO USING BD A-LINE¿, AN UNSPECIFIED NUMBER OF DEVICE PACKAGES WERE TORN, COMPROMISING DEVICE STERILITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21121108 ↗
• MalfunctionNov 26, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED ONE (1) SHELF CARTON OF BD A-LINE¿ SYRINGES DID NOT HAVE A SHELF LABEL. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777536 ↗
• MalfunctionNov 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING A BD A-LINE¿ SYRINGE THERE WAS A CRACK IN THE BARREL WALL CAUSING BLOOD TO LEAK. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758579 ↗
• MalfunctionJul 17, 2024Illegible Information; Illegible Information

  IT WAS REPORTED PRIOR TO USING A BD A-LINE¿ SYRINGE, THE SCALE MARKINGS WERE NOT CLEARLY PRINTED ON THE BARREL. NO IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19768052 ↗
• MalfunctionJun 26, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING THE BD A-LINE¿ THAT THE ORIGINAL PRODUCT LABEL WAS NOT ATTACHED TO THE OUTER PACKAGE. THE ONLY LABEL PRESENT WAS THE JAPANESE LABEL. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616775 ↗
• MalfunctionApr 9, 2024Illegible Information; Illegible Information

  IT WAS REPORTED THAT PRIOR TO USE OF BD A-LINE¿, THE SCALE WAS DISTORTED. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069673 ↗
• MalfunctionMar 14, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT WHILE USING BD A-LINE¿, CLOTTING WAS SEEN IN 5 SYRINGES WITH A KNOWN LOT NUMBER AND AN UNSPECIFIED NUMBER OF SYRINGES WITH UNKNOWN LOT NUMBERS. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902938 ↗