BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11168366 · Received January 13, 2021

    Report

    Report Number
    1920898-2021-00046
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 18, 2020
    Report Date
    March 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. ONE PHOTO OF (1) LOOSE 0.3ML BD INSULIN SYRINGE WAS PROVIDED. THE CUSTOMER REPORTED THAT NEEDLE HUB SEPARATES INTO SHIELD. THE PHOTO WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR OUT OF SPEC SHIELD PULL. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 SYRINGES 0.3ML 8MM 90 BX 450 MO EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NAME OF THE PRODUCT: BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE: CAT # 328291; LOT# 0090638. I RECENTLY BEGAN USING THE 30 UNIT, 8MM, 31G SYRINGES AND HAVE NOTICED THAT IN APPROXIMATELY 1 OUT OF 10 THE PORTION OF THE TOP OF THE SYRINGE THAT HOLDS THE NEEDLE, COMES OFF AND REMAINS IN THE CAP WHEN THE CAP IS REMOVED. I'VE BEEN USING BD SYRINGES SINCE I BECAME DIABETIC IN 1973 AND WON'T USE ANYTHING ELSE, SO THIS IS NOT A COMPLAINT BUT RATHER A NOTIFICATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(4), USA HAS BEEN USED AS A DEFAULT.  A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN , MEDICAL DEVICE EXPIRATION DATE: UNKNOWN , DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0090638, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-03-30. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYRINGES 0.3ML 8MM 90 BX 450 MO EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NAME OF THE PRODUCT: BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE: CAT # 328291, LOT# 0090638. I RECENTLY BEGAN USING THE 30 UNIT, 8MM, 31G SYRINGES AND HAVE NOTICED THAT IN APPROXIMATELY 1 OUT OF 10 THE PORTION OF THE TOP OF THE SYRINGE THAT HOLDS THE NEEDLE, COMES OFF AND REMAINS IN THE CAP WHEN THE CAP IS REMOVED. I'VE BEEN USING BD SYRINGES SINCE I BECAME DIABETIC IN 1973 AND WON'T USE ANYTHING ELSE, SO THIS IS NOT A COMPLAINT BUT RATHER A NOTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55016 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 SEE H10 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1