BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 6MM

    MDR report key: 9880160 · Received March 25, 2020

    Report

    Report Number
    1920898-2020-00306
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 8, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249121
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED (2) LOOSE 1CC SYRINGES. CUSTOMER STATES THAT IT IS TOO HARD FOR HER TO PRESS DOWN DURING INJECTION, ADDING THAT THAT SOMETIMES THE NEEDLE BENT AND ONE TIME IT RESULTED IN SCRATCHING HER SKIN. BOTH RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A BENT CANNULA. BOTH SAMPLES WERE ALSO TESTED AND BOTH WERE ABLE TO DRAW AND EXPEL PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9140729. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT CANNULA). BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (PLUNGER DIFFICULT TO MOVE). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION BENDING OF THE CANNULA DURING ORIGINAL REMOVAL OF THE SHIELDING. IF THE SHIELD IS NOT REMOVED EVENLY AND IN ROUGHLY THE OPPOSITE DIRECTION OF THE FORCE APPLIED, THE CANNULA IS EASILY BENT BY THE SHIELD FLANGE AS THE SHIELD IS REMOVED. TO THE CONSUMER, THIS WOULD APPEAR AS THOUGH THE CANNULA WAS BENT TO BEGIN WITH. ADDITIONALLY, THIS TYPE OF INCIDENT DOES NOT USUALLY LEAVE EVIDENCE ON THE INTERIOR OF THE SHIELD. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 1.0ML 31GA 6MM EXPERIENCED DIFFICULT PLUNGER ROD MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324912 , BATCH NO: 9140729. CONSUMER REPORTED PLUNGERS ARE HARD TO PRESS DOWN DURING INJECTION CONSUMER REPORTED OF THE PLUNGER THAT ARE HARD TO MOVE, BENDS THE NEEDLE AND 1 TIME RESULTED IN SCRATCHING HER SKIN. CONSUMER REPORTED THE SITE IS FINE DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 1.0ML 31GA 6MM EXPERIENCED DIFFICULT PLUNGER ROD MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324912 BATCH NO: 9140729. VERBATIM: CONSUMER REPORTED PLUNGERS ARE HARD TO PRESS DOWN DURING INJECTION CONSUMER REPORTED OF THE PLUNGER THAT ARE HARD TO MOVE, BENDS THE NEEDLE AND 1 TIME RESULTED IN SCRATCHING HER SKIN. CONSUMER REPORTED THE SITE IS FINE. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345053 SYRINGE 1.0ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324912 9140729 00382903249121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other