BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11305354 · Received February 9, 2021

    Report

    Report Number
    1920898-2021-00176
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 19, 2021
    Report Date
    March 5, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2021-02-09 INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 8MM, 31G RELION SYRINGE IN AN OPEN POLY BAG FROM LOT # 0160001. CUSTOMER STATES THAT THERE IS A CLEAR LIQUID IN THE BARREL. THE RETURNED SYRINGE WAS TESTED AND A SMALL CLEAR DROPLET OF MATERIAL CAME OUT OF THE CANNULA WHEN FULLY DEPRESSING THE PLUNGER ROD. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. MAINTENANCE DISPATCH (L2L) #107886 WAS CREATED ON (B)(6) 2020 FOR EXCESSIVE SILICON BEING PUT IN THE BARRELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES ARE MISSING AND THERE IS A CLEAR LIQUID. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 00:17:02: PET OWNER REPORTED, FIND CLEAR LIQUID IN BARREL OF SYRINGE PRIOR TO INJECTION. STATED, SHE DID NOT USE THE SYRINGE STATED, SHE REMOVED A SHIELD PRIOR TO INJECTION AND NEEDLE WAS MISSING. LOT: 0160001 CATALOG: 328512 DATE OF EVENT: 2021-01-19, (NEEDLE MISSING) SAMPLES: YES CL. RECEIVED VOICEMAIL FROM CONSUMER REGARDING NEEDLES MISSING AND NOTICING CLEAR LIQUID BEFORE INJECTION. CL"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES ARE MISSING AND THERE IS A CLEAR LIQUID. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 00:17:02: PET OWNER REPORTED, FIND CLEAR LIQUID IN BARREL OF SYRINGE PRIOR TO INJECTION. STATED, SHE DID NOT USE THE SYRINGE STATED, SHE REMOVED A SHIELD PRIOR TO INJECTION AND NEEDLE WAS MISSING. LOT: 0160001, CATALOG: 328512, DATE OF EVENT: (B)(6) 2021, (NEEDLE MISSING), SAMPLES: YES CL. RECEIVED VOICEMAIL FROM CONSUMER REGARDING NEEDLES MISSING AND NOTICING CLEAR LIQUID BEFORE INJECTION. CL"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198943 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0160001 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1