BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL S/C 200

    MDR report key: 8926579 · Received August 23, 2019

    Report

    Report Number
    1213809-2019-00856
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWENTY-ONE LOOSE 10ML SYRINGES (P/N 302995), SEVENTEEN BLISTER PACKS FROM BATCH 7178949 AND 2 BLISTER PACKS FROM BATCH 8183660 WERE RECEIVED AND VISUALLY INSPECTED. IT APPEARED THE "MOISTURE" WAS SILICONE AND WAS OBSERVED TO BE THE NORMAL AND EXPECTED AMOUNT PER PRODUCT SPECIFICATION ON ALL THE SAMPLES. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL S/C 200 EXPERIENCE LIQUID/MOISTURE/DROPLETS IN THE SYRINGE WHICH WERE NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 302995, BATCH NO. 7178949. A NURSE VISITED ME YESTERDAY WITH A CONCERN ABOUT THE 10ML LUER-LOK TIP SYRINGES THAT WE USE. THE SYRINGES SHE BROUGHT ME HAVE MOISTURE ON THE RUBBER PLUNGER OF THE SYRINGE. SHE WAS CONCERNED BECAUSE SHE HAD BEEN TAUGHT THAT MOISTURE CAN HARBOR BACTERIA. AS FAR AS I KNOW THERE HAVEN¿T BEEN ANY USED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL S/C 200 EXPERIENCE LIQUID/MOISTURE/DROPLETS IN THE SYRINGE WHICH WERE NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 302995, BATCH NO. 7178949. A NURSE VISITED ME YESTERDAY WITH A CONCERN ABOUT THE 10ML LUER-LOK TIP SYRINGES THAT WE USE. THE SYRINGES SHE BROUGHT ME HAVE MOISTURE ON THE RUBBER PLUNGER OF THE SYRINGE. SHE WAS CONCERNED BECAUSE SHE HAD BEEN TAUGHT THAT MOISTURE CAN HARBOR BACTERIA. AS FAR AS I KNOW THERE HAVEN¿T BEEN ANY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721997 SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7178949 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other