BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB

    MDR report key: 12363490 · Received August 24, 2021

    Report

    Report Number
    8041187-2021-00766
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    July 27, 2021
    Report Date
    December 6, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    30382903057802
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: 2021-11-05H6: INVESTIGATION SUMMARY TWO PHOTOS AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTOS, STOPPER MISASSEMBLY IN THE 1ML SYRINGE WAS OBSERVED. FROM THE SAMPLE, STOPPER MISASSEMBLY WAS OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. A SUPPLEMENTAL INVESTIGATION FROM BD CANAAN WAS CONDUCTED. THE QUALITY TEAM FOUND THAT THE SYRINGE HAD A DISTORTED FRONT RIB OF THE STOPPER, WHICH WAS IN THE BOTTOM OUT POSITION. MOISTURE WAS OBSERVED TO BE PRESENT AROUND THE STOPPER, INDICATING THAT IT WAS LIKELY PROPERLY LUBRICATED. UPON SYRINGE DISASSEMBLY IT WAS IMMEDIATELY OBSERVED THAT THE TOP OF THE STOPPER WAS NOT MOLDED PROPERLY HAVING A CAVED IN SURFACE NEAR ITS HOLE AS OPPOSED TO A FLAT SURFACE. THE OBSERVED CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE IMPROPERLY MOLDED STOPPER DEFECT IS ASSOCIATED WITH STOPPER SUPPLIER¿S MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : TWO PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTOS, STOPPER MISASSEMBLY IN THE 1ML SYRINGE WAS OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. A SUPPLEMENTAL INVESTIGATION FROM BD CANAAN WAS CONDUCTED. FROM THE PHOTOS, A SINGLE, LOOSE 1 ML LL SYRINGE WAS OBSERVED NEXT TO A CUSTOMER¿S PACKAGE. THE SYRINGE HAD A DISTORTED FRONT RIB OF THE STOPPER, WHICH WAS IN THE BOTTOM OUT POSITION. MOISTURE WAS OBSERVED TO BE PRESENT AROUND THE STOPPER, INDICATING THAT IT WAS LIKELY PROPERLY LUBRICATED. IT WAS NOT CLEAR FROM THE IMAGES IF THE STOPPER WAS DAMAGED OR HAD A DEFORMED SHAPE FROM MANUFACTURING. A PHYSICAL SAMPLE IS NECESSARY FOR FURTHER INVESTIGATION. A POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT COULD NOT BE DETERMINED BASED ON THE PHOTOS PROVIDED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB STOPPER WAS DEFECTIVE/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFORMATION OF THE RUBBER PLUG AT THE FRONT END OF THE SYRINGE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB STOPPER WAS DEFECTIVE/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFORMATION OF THE RUBBER PLUG AT THE FRONT END OF THE SYRINGE"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE TYPE: FMI. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K941562 (SYRINGE). PMA / 510(K)#: K161170 (NEEDLE). 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 SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB STOPPER WAS DEFECTIVE/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFORMATION OF THE RUBBER PLUG AT THE FRONT END OF THE SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260051 SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB PISTON SRYINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 305780 1040161 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown