BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 10752313 · Received October 28, 2020

    Report

    Report Number
    1213809-2020-00758
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 1, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/22/2020. H.6. INVESTIGATION: ONE PHOTO AND ONE 10ML SYRINGE, REPORTEDLY FILLED WITH ROCURONIUM BROMIDE, WERE RECEIVED AND VISUALLY EVALUATED. DUE TO POTENTIAL RISK INVOLVED WITH DIRECT SAMPLE HANDLING, THE SYRINGE WAS EVALUATED THROUGH THE BAG WITH MAGNIFICATION ASSISTANCE. IN BOTH THE PHOTO AND THE PHYSICAL SAMPLE, THE REPORTED FOREIGN MATTER DEFECT APPEARED TO BE A SMALL AIR BUBBLE ON TOP OF THE STOPPER. AN AIR BUBBLE IS NOT FOREIGN MATTER AND IS NOT A MANUFACTURING DEFECT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 10ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEREBY I WOULD LIKE TO REPORT A COMPLAINT REGARDING ARTICLE V62.301029 BATCHES 9241688/ 9247681/ 9081846/ 9108747. DURING A PREPARATION A WHITE PARTICLE WAS FOUND ON THE BLACK RUBBER IN A 10ML SYRINGE. THE SYRINGE IS FILLED WITH ROCURONIUM BROMIDE AND I DON'T WANT TO EMPTY THE SYRINGE BECAUSE I'M AFRAID I'LL REMOVE THE PARTICLE AS WELL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). THERE WERE MULTIPLE LOT NUMBERS THAT MAY HAVE BEEN INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9241688 , MEDICAL DEVICE EXPIRATION DATE: 2020-07-24, DEVICE MANUFACTURE DATE: 2019-09-03. MEDICAL DEVICE LOT #: 9247681 , MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-09-27. MEDICAL DEVICE LOT #: 9081846 , MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-10-04. MEDICAL DEVICE LOT #: 9108747 , MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, EVICE MANUFACTURE DATE: 2019-05-04.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 10ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEREBY I WOULD LIKE TO REPORT A COMPLAINT REGARDING ARTICLE V62.301029 BATCHES 9241688/ 9247681/ 9081846/ 9108747. DURING A PREPARATION A WHITE PARTICLE WAS FOUND ON THE BLACK RUBBER IN A 10ML SYRINGE. THE SYRINGE IS FILLED WITH ROCURONIUM BROMIDE AND I DON'T WANT TO EMPTY THE SYRINGE BECAUSE I'M AFRAID I'LL REMOVE THE PARTICLE AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214313 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1