BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 9309146 · Received November 12, 2019

    Report

    Report Number
    1920898-2019-01269
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 25, 2019
    Report Date
    January 8, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 3 DECEMBER 2019 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8169616. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (2) 1CC, 8MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 8169616. CUSTOMER ALSO RETURNED (1) 1/2CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 9028764 FOR COMPARISON. CUSTOMER STATES THAT THE 1ML SYRINGE NEEDLE IS LONGER THAN THE .5ML SYRINGE NEEDLE WHEN BOTH ARE 8MM IN LENGTH. ALL RETURNED SYRINGES WERE TESTED USING THE LENGTH GAUGE AND ALL CANNULA LENGTHS FELL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8169616. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT TWO SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS HAVE BEEN FOUND WITH TOO LONG OF CANNULAS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE 1ML SYRINGE NEEDLE IS LONGER THAN THE .5ML SYRINGE NEEDLE WHEN BOTH ARE 8MM IN LENGTH. VERBATIM: ISSUE: CONSUMER REPORTED HIS 1ML,31G,8MM NEEDLE IS LONGER THAN THE 1/2ML,8MM,31G NEEDLE, HE COMPARED IT NEXT TO EACH OTHER AND NOTICES ITS LONGER. SAMPLE AVAILABLE, HE BOUGHT THE BOX YESTERDAY. INCIDENT DATE-10-25-2019. OCCURENCE-2. ITEM# 328418. LOT# 8169616 C EXPIRATION DATE-2018-07-01-20123-08-30. ITEM# 328468 1SYRINGE HE WILL BE SENDING ONE SAMPLE OF THIS NEEDLE FOR COMPARISON. LOT 90278764. A CONSUMER USES NEW SYRINGES FOR HIS INJECTION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT TWO SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS HAVE BEEN FOUND WITH TOO LONG OF CANNULAS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE 1ML SYRINGE NEEDLE IS LONGER THAN THE .5ML SYRINGE NEEDLE WHEN BOTH ARE 8MM IN LENGTH. VERBATIM: ISSUE: CONSUMER REPORTED HIS 1ML,31G,8MM NEEDLE IS LONGER THAN THE 1/2ML,8MM,31G NEEDLE, HE COMPARED IT NEXT TO EACH OTHER AND NOTICES ITS LONGER. SAMPLE AVAILABLE, HE BOUGHT THE BOX YESTERDAY INCIDENT DATE- (B)(6) 2019; OCCURENCE-2; ITEM# 328418; LOT# 8169616 C EXPIRATION DATE-2018-07-01-20123-08-30. ITEM# 328468 1SYRINGE HE WILL BE SENDING ONE SAMPLE OF THIS NEEDLE FOR COMPARISON. LOT 90278764 A CONSUMER USES NEW SYRINGES FOR HIS INJECTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT TWO SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS HAVE BEEN FOUND WITH TOO LONG OF CANNULAS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE 1ML SYRINGE NEEDLE IS LONGER THAN THE .5ML SYRINGE NEEDLE WHEN BOTH ARE 8MM IN LENGTH. VERBATIM: ISSUE: CONSUMER REPORTED HIS 1ML,31G,8MM NEEDLE IS LONGER THAN THE 1/2ML,8MM,31G NEEDLE, HE COMPARED IT NEXT TO EACH OTHER AND NOTICES ITS LONGER. SAMPLE AVAILABLE, HE BOUGHT THE BOX YESTERDAY. INCIDENT DATE-(B)(6) 2019, OCCURENCE-2, ITEM#: 328418, LOT#: 8169616, C EXPIRATION DATE-2018-07-01-20123-08-30. ITEM#: 328468 1SYRINGE. HE WILL BE SENDING ONE SAMPLE OF THIS NEEDLE FOR COMPARISON. LOT 90278764 A. CONSUMER USES NEW SYRINGES FOR HIS INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103250 SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8169616 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other