BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 6MM S/C U-100 RELION

    MDR report key: 11276115 · Received February 3, 2021

    Report

    Report Number
    2243072-2021-00212
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL - DIABETES CARE (HOLDREGE) G.1. MANUFACTURING LOCATION: BD MEDICAL - DIABETES CARE (HOLDREGE) D.4. MEDICAL DEVICE LOT #: UNKNOWN D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN D.4. MEDICAL DEVICE LOT #: 0132212 D.4. MEDICAL DEVICE EXPIRATION DATE: NA H.4. DEVICE MANUFACTURE DATE: 10/7/2020 D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 3/16/2021 H.6. INVESTIGATION: CUSTOMER RETURNED A SINGLE SYRINGE WITH RELI-ON POUCH, INDICATING THAT IT IS A 0.3ML 31 GAUGE 6MM SYRINGE FROM LOT 0132212. THE SYRINGE WAS RETURNED WITH THE NEEDLE HUB AND SHIELD SEPARATED FROM THE BARREL. THERE IS NO DAMAGE TO THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR THE BASE OF THE NEEDLE HUB. NO SIGNS OF USE. NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0132212 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200905593] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200905966] NOTED FOR RAISED SHIELDS. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED. SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31G 6MM S/C U-100 RELION SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED WHEN THE SHIELD WAS REMOVED. VERBATIM: CONSUMER REPORTED DOES NOT HAVE WITH HER RIGHT NOW. FIND 1 SYRINGE WHEN REMOVE SHIELD NEEDLE HUB REMOVES LOT #: UNKNOWNCATALOG#: 328521DATE OF EVENT: (B)(6) 2021 SAMPLES STATUS AWAITING SAMPLE".

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4)."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31G 6MM S/C U-100 RELION SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED WHEN THE SHIELD WAS REMOVED. VERBATIM: CONSUMER REPORTED DOES NOT HAVE WITH HER RIGHT NOW. FIND 1 SYRINGE WHEN REMOVE SHIELD NEEDLE HUB REMOVES LOT #: UNKNOWN CATALOG#: 328521. DATE OF EVENT: (B)(6) 2021. SAMPLES STATUS: AWAITING SAMPLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173109 SYRINGE 0.3ML 31G 6MM S/C U-100 RELION PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328521 UNKNOWN 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1