BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL S/C 200

    MDR report key: 10892039 · Received November 24, 2020

    Report

    Report Number
    1213809-2020-00827
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    August 14, 2020
    Report Date
    December 23, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE LOOSE 5ML SYRINGE AND TWO OPENED AND EMPTY BLISTER PACKS (P/N 302995) WERE RECEIVED AND EVALUATED. ONE PACKAGE WAS FROM BATCH 0090224 AND ONE PACKAGE WAS FROM BATCH 0113963. IT WAS OBSERVED THE SYRINGE HAD A PORTION OF THE STOPPER WEDGED BETWEEN THE BOTTOM OF THE PLUNGER ROD AND BARREL WALL. THE JAMMED STOPPER CONDITION WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 0090224 AND 0113963 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 SYRINGE 10ML LL S/C 200 PLUNGER WAS DEFORMED. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 302995 BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THE SYRINGE HAD A DEFORMED PLUNGER. VERBATIM: CUSTOMER PROVIDED TWO POSSIBLE LOT #'S ( 0090224 OR 0113963) RN WAS DRAWING UP PRESCRIBED HEPARIN FOR HEMODIALYSIS AND NOTICE A DEFORMED PLUNGER ON THE BD10ML SYRINGE. RN DISCARDED MEDICATION AND SAVED SYRINGE FOR REPORTING. DID NOT REACH PATIENT.

    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 #: UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0090224; MEDICAL DEVICE EXPIRATION DATE: 2025-03-31; DEVICE MANUFACTURE DATE: 2020-03-30. MEDICAL DEVICE LOT #: 0113963; MEDICAL DEVICE EXPIRATION DATE: 2025-04-30; DEVICE MANUFACTURE DATE: 2020-04-22. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 PLUNGER WAS DEFORMED. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 302995; BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THE SYRINGE HAD A DEFORMED PLUNGER. VERBATIM: CUSTOMER PROVIDED TWO POSSIBLE LOT #'S ( 0090224 OR 0113963) RN WAS DRAWING UP PRESCRIBED HEPARIN FOR HEMODIALYSIS AND NOTICE A DEFORMED PLUNGER ON THE BD10ML SYRINGE. RN DISCARDED MEDICATION AND SAVED SYRINGE FOR REPORTING. DID NOT REACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360565 SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 SEE H.10 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1