BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7500914 · Received May 9, 2018

    Report

    Report Number
    1213809-2018-00274
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 23, 2018
    Report Date
    May 25, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096053
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SAMPLE EVALUATION: A TOTAL OF TEN LOOSE 10ML LUER-LOK SYRINGES WERE RECEIVED, REPORTED TO BE FROM BATCH # 7026960, 7058747, 7086602 OR 7121511 (P/N 309605). THE SAMPLES WERE VISUALLY EVALUATED. ALL SAMPLES WERE FOUND TO HAVE A SMALL SCUFF MARK LOCATED NEXT TO THE LEFT SIDE OF THE ZERO LINE, APPROXIMATELY 1/16" LONG AND A SCRATCH MARK ON THE BARREL WALL OUTSIDE SCALE MARKINGS 1/8" LONG. NO OTHER DEFECTS WERE OBSERVED IN THE SYRINGES. THE SCRATCH AND SCUFF MARKS OBSERVED DO NOT AFFECT THE FIT, FORM OR FUNCTION OF THE SYRINGES AND ARE CONSIDERED A COSMETIC DEFECT. DHR REVIEW FOR BATCH 7121511 (P/N 309605): MANUFACTURING DATES: 06/09/2017 TO 06/10/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7121511 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7086602 (P/N 309605): MANUFACTURING DATES: 05/13/2017 TO 05/14/2017. BATCH QUANTITY WAS 172,800. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7086602 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7058747 (P/N 309605): MANUFACTURING DATES: 03/21/2017 TO 03/22/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7058747 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7026960 (P/N 309605): MANUFACTURING DATES: 01/31/2017 TO 02/02/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7026960 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION: UNCONFIRMED: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE.

    Additional Manufacturer Narrative · 1

    "THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7026960; MEDICAL DEVICE EXPIRATION DATE: 01/31/2022; DEVICE MANUFACTURE DATE: 02/06/2017; MEDICAL DEVICE LOT #: 7058747; MEDICAL DEVICE EXPIRATION DATE: 02/28/2022; DEVICE MANUFACTURE DATE: 03/27/2017. MEDICAL DEVICE LOT #: 7086602; MEDICAL DEVICE EXPIRATION DATE: 03/31/2022; DEVICE MANUFACTURE DATE: 05/18/2017. MEDICAL DEVICE LOT #: 7121511; MEDICAL DEVICE EXPIRATION DATE: 04/30/2022; DEVICE MANUFACTURE DATE: 06/15/2017. 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 CRACK WAS FOUND IN THE BARREL OF THE SYRINGE OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY. IT IS UNCLEAR WHEN THE TIME OF EVENTS OCCURRED. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343154 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 00382903096053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other