BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8617017 · Received May 16, 2019

    Report

    Report Number
    3003152976-2019-00327
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 29, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903008650
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DAMAGE WAS OBSERVED AT THE 20ML MARKING. THE DAMAGE IS CONSISTENT WITH THE TRANSFER WHEELS USED TO MOVE THE PRODUCT THROUGHOUT THE ASSEMBLY MACHINE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 1902236 AND 1902252, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. RETAINED SAMPLES FROM EACH LOT WERE INSPECTED, NO DAMAGE IDENTIFIED IN ANY OF THE PRODUCT EVALUATED. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INSTANCE OCCURRED DUE TO THE PRODUCT GETTING JAMMED IN THE MANUFACTURING EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRACKED BARREL OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE HAVE HAD 3 X INCIDENTS OF BD PLASTIPAK SYRINGES WITH VISIBLE CRACKS, INFILTRATING AIR. ARE YOU AWARE OF ANY BATCH ISSUE IN THE UK? UNFORTUNATELY THE NURSING STAFF DID NOT RECORD THE LOT NUMBERS, SO WE HAVE GATHERED THE LOT NUMBERS IN STOCK AT THE TIME; LOT: 1902252, LOT: 1902236. THESE HAVE BEEN REMOVED FROM THE CLINICAL AREAS. NO HARM CAME TO THE PATIENTS AS A RESULT OF THE INCIDENTS, SO FAR THERE HAVE BEEN 3."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1902252, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-02-04. MEDICAL DEVICE LOT #: 1902236, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-02-25. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRACKED BARREL OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE HAVE HAD 3 X INCIDENTS OF BD PLASTIPAK SYRINGES WITH VISIBLE CRACKS, INFILTRATING AIR. ARE YOU AWARE OF ANY BATCH ISSUE IN THE UK? UNFORTUNATELY THE NURSING STAFF DID NOT RECORD THE LOT NUMBERS, SO WE HAVE GATHERED THE LOT NUMBERS IN STOCK AT THE TIME; LOT: 1902252, LOT: 1902236. THESE HAVE BEEN REMOVED FROM THE CLINICAL AREAS. NO HARM CAME TO THE PATIENTS AS A RESULT OF THE INCIDENTS, SO FAR THERE HAVE BEEN 3."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408003 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE WITH NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other