BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31GA 6MM

    MDR report key: 10271518 · Received July 14, 2020

    Report

    Report Number
    1920898-2020-00850
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 23, 2020
    Report Date
    July 16, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED TWO (2) LOOSE 0.3ML BD INSULIN SYRINGES. CONSUMER REPORTED THAT THE SHIELD WAS DIFFICULT TO REMOVE AND THE NEEDLE HUB SEPARATES WHEN REMOVING SHIELD; ALSO REPORTED THAT SCALE MARKINGS ARE DIFFICULT TO READ. BOTH RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT BOTH SYRINGES EXHIBITED A NEEDLE HUB/SHIELD ASSEMBLY SEPARATED FROM THE SYRINGE BARREL; NO DAMAGE TO THE BARREL TIPS WAS OBSERVED. NO EVIDENCE OF MANUFACTURING DEFECT REGARDING THE SCALE MARKING WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200845676] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200845565] NOTED FOR MISSING ZERO LINE. THERE WERE TWO (2) NOTIFICATIONS [200845567, 200845495] NOTED FOR OUT OF SPEC SHIELD PULL. BASED ON THE SAMPLES RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SCALE MARKING LIGHT/ILLEGIBLE). ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA 1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB SEPARATES FROM DEVICE 15 TIMES AND SCALE MARKING ARE DIFFICULT TO READ PRIOR TO USE WITH A BD SYRINGE 0.3ML 31GA 6MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE HUB SEPARATES WHEN REMOVING SHIELD. ALSO REPORTED THAT SCALE MARKINGS ARE DIFFICULT TO READ.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUB SEPARATES FROM DEVICE 15 TIMES AND SCALE MARKING ARE DIFFICULT TO READ PRIOR TO USE WITH A BD SYRINGE 0.3ML 31GA 6MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE HUB SEPARATES WHEN REMOVING SHIELD. ALSO REPORTED THAT SCALE MARKINGS ARE DIFFICULT TO READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738040 BD SYRINGE 0.3ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 9252570 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other