BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31GA 6MM

    MDR report key: 11178080 · Received January 15, 2021

    Report

    Report Number
    1920898-2021-00066
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 21, 2020
    Report Date
    March 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. FOUR PHOTOS OF (1) 0.3ML BD INSULIN SYRINGE FROM LOT# 0020542 WERE PROVIDED. THE CUSTOMER REPORTED WHEN REMOVING (CAREFULLY) THE ORANGE PROTECTIVE CAP FROM THE NEEDLE IN TWO SYRINGES FROM THIS BATCH, THEY DETACHED (TOGETHER WITH THE PLASTIC PART) GETTING STUCK IN THE PROTECTIVE COVER. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY SEPARATED FROM THE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0020542. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 0.3ML 31GA 6MM THE NEEDLE HUB SEPARATED FROM DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: (1 OF 2 COMPLAINTS): INFORMS THAT HE APPLIES INSULIN TO HIS FATHER AND IN THE LAST BATCH TWO (2) SYRINGES SHOWED THE FOLLOWING QUALITY DEVIATION: WHEN REMOVING (CAREFULLY) THE ORANGE PROTECTIVE CAP FROM THE NEEDLE IN TWO SYRINGES FROM THIS BATCH, THEY DETACHED (TOGETHER WITH THE PLASTIC PART) GETTING STUCK IN THE PROTECTIVE COVER. HE DOES NOT REUSE THE DEVICE. IT DID NOT CAUSE ANY DAMAGE TO HEALTH.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD SYRINGE 0.3ML 31GA 6MM THE NEEDLE HUB SEPARATED FROM DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: (1 OF 2 COMPLAINTS) INFORMS THAT HE APPLIES INSULIN TO HIS FATHER AND IN THE LAST BATCH TWO (2) SYRINGES SHOWED THE FOLLOWING QUALITY DEVIATION: WHEN REMOVING (CAREFULLY) THE ORANGE PROTECTIVE CAP FROM THE NEEDLE IN TWO SYRINGES FROM THIS BATCH, THEY DETACHED (TOGETHER WITH THE PLASTIC PART) GETTING STUCK IN THE PROTECTIVE COVER. HE DOES NOT REUSE THE DEVICE. IT DID NOT CAUSE ANY DAMAGE TO HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73329 BD SYRINGE 0.3ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0020542

    Patients

    Seq Age Sex Outcome Treatment
    1