BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA

    MDR report key: 11646445 · Received April 10, 2021

    Report

    Report Number
    1920898-2021-00391
    Event Type
    Malfunction
    Date Received
    April 10, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. FOUR PHOTOS 0.3ML BD INSULIN SYRINGES WERE PROVIDED. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT ONE OF THE SYRINGES EXHIBITED MISSING SCALE MARKINGS. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED MISSING SCALE MARKINGS. 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 WAS ONE (1) NOTIFICATION NOTED FOR MISSING PRINT. CUSTOMER RETURNED SEVERAL IMAGES, SHOWING MULTIPLE SYRINGES AND A POUCH LABELED FOR 0.3ML, 31 GAUGE, 6MM SYRINGES FROM LOT 0020542. ONE SYRINGE HAS A NEEDLE LENGTH SIGNIFICANTLY LONGER THAN THE OTHERS. IT CANNOT BE DETERMINED IF A POUCH OF SYRINGES WITH AN INSUFFICIENT NEEDLE LENGTH WAS SENT IN ERROR OR IF THE SYRINGES IN THE POUCH WERE INSUFFICIENT USING THE INFORMATION AVAILABLE. HOWEVER, PACKAGING FOR THIS PARTICULAR SET OF SYRINGES APPEARS TO MATCH THE SYRINGES INSIDE USING THE LIMITED INFORMATION AVAILABLE WITHOUT THE SAMPLES. IT WAS NOTED THAT ONE SYRINGE WITH A SHORTER NEEDLE AND THE ONE SYRINGE WITH A LONGER NEEDLE WERE BOTH BENT. HIGH ENOUGH FORCES PLACED ACROSS THE LENGTH OF THE NEEDLE MAY HAVE BEEN SUFFICIENT ENOUGH TO RESULT IN THE NEEDLE BENDING. 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. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF ONE OF THE NEEDLES BENDING. BASED ON THE SAMPLES RECEIVED, BD WAS UNABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE DIMENSIONS OF THE SYRINGE BEING INCORRECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA HAD INSUFFICIENT CANNULA LENGTH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PHARMACIST REPORTS THAT THE CAREGIVER REQUESTED FOR THE EXCHANGE OF A PACK OF SYRINGES THAT HAVE COME IN A SMALLER SIZE THAN USUAL, AND THEY ARE BENDING AT THE APPLYING MOMENT. REPORTS THAT THE CAREGIVER APPLIES IN HER CAT AND THE NEEDLES ARE TOO SHORT AND BENDING".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER LAST NAME: (B)(6) DATE OF EVENT: UNKNOWN. . 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 WAS REPORTED THAT 2 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA HAD INSUFFICIENT CANNULA LENGTH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PHARMACIST REPORTS THAT THE CAREGIVER REQUESTED FOR THE EXCHANGE OF A PACK OF SYRINGES THAT HAVE COME IN A SMALLER SIZE THAN USUAL, AND THEY ARE BENDING AT THE APPLYING MOMENT. REPORTS THAT THE CAREGIVER APPLIES IN HER CAT AND THE NEEDLES ARE TOO SHORT AND BENDING"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543946 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA PISTON SYRINGE FMF BECTON DICKINSON 0020542

    Patients

    Seq Age Sex Outcome Treatment
    1