BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 11061163 · Received December 22, 2020

    Report

    Report Number
    1213809-2020-00915
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 24, 2020
    Report Date
    February 8, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/4/2020. H.6. INVESTIGATION: FOUR LOOSE AND THREE SEALED PACKAGED 3ML SYRINGES WERE RECEIVED, WITH PACKAGES CONFIRMED TO BE FROM BATCH #0143009 (P/N 309657). THE SAMPLES WERE VISUALLY EVALUATED. NO LIQUID WAS FOUND IN ANY OF THE RETURNED SAMPLES. THE STOPPERS OF ALL SYRINGES WERE OBSERVED TO HAVE A UNIFORM COATING OF SILICONE VISIBLE AS A LIGHT SHEEN ON THEIR SURFACE. NO EXCESS POOLING WAS FOUND IN ANY SAMPLES. THE AMOUNT OF SILICONE OBSERVED WAS NORMAL AND EXPECTED AMOUNT FOR THIS PRODUCT PER PRODUCT SPECIFICATION. NO DEFECTS FOUND IN THE RETURNED SAMPLES. 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 3ML LL 200 S/C CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO.: 309657 BATCH NO.: 0143009. IT WAS REPORTED THAT THERE IS A LIQUID INSIDE THE SYRINGE. PER SNOW RECORD: PHARMACIST CALLING IN REGARDS TO THE CONCERN WITH THE SYRINGES WITH MATERIAL# 309657 LOT# 0143009, STATING THAT THERE IS A FM LIQUID IN THE SYRINGE, SAMPLE AVAILABLE: YES."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 3ML LL 200 S/C CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657, BATCH NO.: 0143009. IT WAS REPORTED THAT THERE IS A LIQUID INSIDE THE SYRINGE. PER SNOW RECORD: PHARMACIST CALLING IN REGARDS TO THE CONCERN WITH THE SYRINGES WITH MATERIAL# 309657, LOT# 0143009, STATING THAT THERE IS A FM LIQUID IN THE SYRINGE, SAMPLE AVAILABLE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523604 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0143009 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1