BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8617813 · Received May 16, 2019

    Report

    Report Number
    3003152976-2019-00329
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 1, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    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

    H.6. INVESTIGATION: FIVE SAMPLES AND ONE PHOTO WERE PROVIDED FOR INVESTIGATION. UPON INSPECTING THE PRODUCT, DAMAGE IS OBSERVED NEAR THE 20ML MARKING. DUE TO THE DENTING NOTED IN THIS AREA, THE STOPPER BECOMES DISTORTED WHEN MOVED ACROSS THIS POINT, RESULTING IN THE LEAK THAT WAS REPORTED. THE DAMAGE IS CONSISTENT WITH THE TRANSFER WHEELS USED TO MOVE THE PRODUCT WITHIN THE ASSEMBLY STATION. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1902236 AND 1902252 THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. RETAINED SAMPLES OF THESE LOTS WERE INSPECTED, NO DAMAGED OR DEFECTS WERE IDENTIFIED IN ANY OF THE BARRELS EVALUATED. WHILE A REVIEW OF MANUFACTURING RECORDS ESTABLISHED ALL QUALITY PROCESSES WERE CARRIED OUT NORMALLY, IT WAS DETERMINED THIS INCIDENT OCCURRED DUE TO THE PRODUCT JAMMING IN THE MANUFACTURING EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE UNFORTUNATELY HAD ANOTHER INCIDENT OF A DAMAGED SYRINGE TODAY ON ICU. NO HARM CAME TO THE PATIENT AS A RESULT AS THE NURSE SPOTTING THE ISSUE VERY QUICKLY. IT APPEARS THAT THERE ARE TWO IDENTICAL ¿DENTS¿ AROUND THE 20MLS MARK. THE PLASTIC IS NOT SPLIT. THE SYRINGE RUNS NORMALLY UNTIL IT REACHES THE 20ML MARK AND IT APPEARS THE PLUNGER LOSES ITS SEAL OVER THE DAMAGED AREA AND AIR THEN ENTERS THE SYRINGE, CAUSING RAPID INFUSION OF MEDICATION AND THEN AIR. IT APPEARS ONE OF THE BATCH NUMBERS WE REMOVED YESTERDAY WAS MISSED IN A BEDSIDE CABINET AND WAS USED TODAY, WE ARE CURRENTLY RECHECKING THE BEDSIDES FOR ANY OTHERS. WE HAVE HAD 3 X INCIDENTS OF BD PLASTIPAK SYRINGES WITH VISIBLE CRACKS, INFILTRATING AIR. NO HARM CAME TO THE PATIENTS AS A RESULT OF THE INCIDENTS, SO FAR THERE HAVE BEEN 3.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: 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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE UNFORTUNATELY HAD ANOTHER INCIDENT OF A DAMAGED SYRINGE TODAY ON ICU. NO HARM CAME TO THE PATIENT AS A RESULT AS THE NURSE SPOTTING THE ISSUE VERY QUICKLY. IT APPEARS THAT THERE ARE TWO IDENTICAL ¿DENTS¿ AROUND THE 20MLS MARK. THE PLASTIC IS NOT SPLIT. THE SYRINGE RUNS NORMALLY UNTIL IT REACHES THE 20ML MARK AND IT APPEARS THE PLUNGER LOSES ITS SEAL OVER THE DAMAGED AREA AND AIR THEN ENTERS THE SYRINGE, CAUSING RAPID INFUSION OF MEDICATION AND THEN AIR. IT APPEARS ONE OF THE BATCH NUMBERS WE REMOVED YESTERDAY WAS MISSED IN A BEDSIDE CABINET AND WAS USED TODAY, WE ARE CURRENTLY RECHECKING THE BEDSIDES FOR ANY OTHERS. WE HAVE HAD 3 X INCIDENTS OF BD PLASTIPAK SYRINGES WITH VISIBLE CRACKS, INFILTRATING AIR. 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
    408032 BD PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other