BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7298183 · Received February 26, 2018

    Report

    Report Number
    1213809-2018-00062
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 27, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: NINE LOOSE 3ML ASSEMBLED SYRINGES WERE RECEIVED BY BD (B)(4) FROM UNKNOWN BATCH #. THE REPORTED BATCHES WERE EITHER #7151817 OR 7157513 OR 7157517 (P/N 301073). THE SAMPLES WERE VISUALLY EVALUATED. DURING THE EVALUATION THE PLUNGER/STOPPER ASSEMBLY WAS MOVED TO VERIFY FUNCTION. NO DEFECTS WERE FOUND. BAG 1 ¿ ¿FROM PACK PLUNGERS DEFORMED¿ ¿ 3 SYRINGES. NO VISUAL DEFECTS OBSERVED. BAG 2 ¿ ¿SYRINGES FROM PACK KEEP GETTING AIR BUBBLES¿ ¿ 2 SYRINGES. ONE SYRINGE HAD A BLANK LABEL ATTACHED. NO VISUAL DEFECTS OBSERVED BAG 3 ¿ ¿FROM PACK DEFECTIVE ALLOWS AIR AROUND THE PLUNGER¿ ¿ 4 SYRINGES. NO VISUAL DEFECTS OBSERVED. 1 OF THE 4 SYRINGES WAS A MONOJECT SYRINGE WHICH WAS NOT MANUFACTURED AT CANAAN. A LABEL WAS ATTACHED TO THIS SYRINGE WHICH READ ¿GOOD FROM OR.¿ NO DEFECTS WERE FOUND OR OBSERVED DURING THIS EVALUATION. BASED ON DESCRIPTIONS, THE SAMPLES WERE POTENTIALLY USED AND CONTAMINATED THEREFORE NO ADDITIONAL FUNCTIONAL TESTING WAS PERFORMED. DHR REVIEW FOR BATCH 7151817 (P/N 301073): MANUFACTURING DATE: 6/2/2017 TO 6/3/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7151817 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7157513 (P/N 301073): MANUFACTURING DATE: 6/17/2017 TO 6/26/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7157513 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7157517 (P/N 301073): MANUFACTURING DATE: 7/09/2017 TO 7/12/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7157517 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION: ¿ UNCONFIRMED: BD (B)(4) WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. INVESTIGATION CONCLUSION: ROOT CAUSE UNDETERMINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THREE POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7151817; MEDICAL DEVICE EXPIRATION DATE: 05/31/2022; DEVICE MANUFACTURE DATE: 05/31/2017. MEDICAL DEVICE LOT #: 7157513; MEDICAL DEVICE EXPIRATION DATE: 05/31/2022; DEVICE MANUFACTURE DATE: 06/06/ 2017. MEDICAL DEVICE LOT #: 7157517; MEDICAL DEVICE EXPIRATION DATE: 05/31/2022; DEVICE MANUFACTURE DATE: 05/31/2017. 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 THE STOPPER ON A BD LUER-LOK¿ SYRINGE WAS FOUND DEFECTIVE "NOT TIGHT" CAUSING AIR BUBBLES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141675 BD LUER-LOK¿ SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other