BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE INTEGRA 3ML W/NDL 23X1 RB

    MDR report key: 10578297 · Received September 24, 2020

    Report

    Report Number
    1213809-2020-00654
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052715
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 SYRINGES INTEGRA 3ML W/NDL 23X1 RB EXPERIENCED PREMATURE NEEDLE RETRACTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER PROVIDED PRODUCT INFORMATION IN EMAIL OF COMPLAINT TAKEN. STATED, WHEN TAKING INJECTION, THE SPRING POPS LOSE AND IS FLOATING AROUND INSIDE THE BARREL WITH MEDICATION. STATED, HE'S WASTING MEDICATION PROVIDED PHARMACY INFORMATION AND CONFIRMED ADDRESS. LOT: 8211538; CATALOG: 305271; DATE OF EVENT: (B)(6) 2020. MAJOR CONCERN OVER A LOT OF BD INTEGRA SYRINGE 3ML 23G X 1. I USE THESE TO TAKE MY PRESCRIBED MEDICINE. I REQUIRE .75ML. EVERYTIME I USE, THE SPRING POPS DURING INJECTION AND THE MEDICINE IS LEFT IN THE SYRINGE AND THE NEEDLE RETRACTS. THIS CAUSES MY MEDICINE TO BE WASTED AND IT'S A VERY COSTLY MEDICINE. THIS HAPPENED WITH 4 DIFFERENT SYRINGES TODAY (B)(6) 2020).

    Additional Manufacturer Narrative · 1

    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 THAT 4 SYRINGES INTEGRA 3ML W/NDL 23X1 RB EXPERIENCED PREMATURE NEEDLE RETRACTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER PROVIDED PRODUCT INFORMATION IN EMAIL OF COMPLAINT TAKEN. STATED, WHEN TAKING INJECTION, THE SPRING POPS LOSE AND IS FLOATING AROUND INSIDE THE BARREL WITH MEDICATION. STATED, HE'S WASTING MEDICATION PROVIDED PHARMACY INFORMATION AND CONFIRMED ADDRESS. LOT: 8211538. CATALOG: 305271. DATE OF EVENT: (B)(6) 2020. MAJOR CONCERN OVER A LOT OF BD INTEGRA SYRINGE 3ML 23G X 1. I USE THESE TO TAKE MY PRESCRIBED MEDICINE. I REQUIRE .75ML. EVERYTIME I USE, THE SPRING POPS DURING INJECTION AND THE MEDICINE IS LEFT IN THE SYRINGE AND THE NEEDLE RETRACTS. THIS CAUSES MY MEDICINE TO BE WASTED AND IT'S A VERY COSTLY MEDICINE. THIS HAPPENED WITH 4 DIFFERENT SYRINGES TODAY ((B)(6) 2020).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043151 SYRINGE INTEGRA 3ML W/NDL 23X1 RB PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305271 8211538 30382903052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other