BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE NEEDLE INSULIN SYRINGE

    MDR report key: 8536123 · Received April 22, 2019

    Report

    Report Number
    1920898-2019-00366
    Event Type
    Malfunction
    Date Received
    April 22, 2019
    Date of Event
    April 4, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282807
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) 3/10CC, 12.7MM, 30G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7072979. CUSTOMER STATES THAT THE PLUNGER WAS DIFFICULT TO PULL UP AND THERE IS A CRACK IN THE SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED CRACKS IN THE BARREL RANGING FROM THE 22 UNIT MARKING TO PAST THE 30 UNIT MARKING. SEE ATTACHED PHOTO. THE SAMPLE WAS ALSO TESTED AND THE PLUNGER ROD WAS ABLE TO BE EXERCISED IN THE BARREL WITHOUT NAY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7072979 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR DRY BARRELS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR DAMAGED SHIELDS. THERE WERE FOUR (4) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CRACKED BARREL). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (PLUNGER ROD DIFFICULT TO MOVE). POSSIBLE ROOT CAUSES: DEFECT COULD HAVE OCCURRED AT THE PREP DIAL OF THE METRO ASSEMBLY MACHINE LOSS OF BACK PRESSURE ON THE IN-FEED RAIL MAY CAUSE THE BARREL TO BECOME PINCHED AT THE RAIL / PREP DIAL JUNCTION. THE TRIP GATE EYE SENSOR SHOULD DETECT LOW RAIL CONDITIONS AND ACTIVATE THE TRIP GATE TO PREVENT THE BARRELS FROM BEING LOADED INTO THE PREP DIAL AND POSSIBLY JAMMING AT THAT LOCATION. .INFEED DIAL AT BARREL PRINTERS. LOSS OF BACK PRESSURE AT INFEED RAIL ALSO AT FORM FILL & SEAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE PLUNGER IS DIFFICULT TO MOVE AND THERE IS A CRACK IN THE SYRINGE BARREL. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328280 BATCH NO. 7072979 IT WAS REPORTED THAT PLUNGER IS DIFFICULT TO MOVE AND THERE IS A CRACK IN THE BARREL OF THE SYRINGE. VERBATIM: RECEIVED LETTER AND SAMPLE FROM CONSUMER REPORTING A CRACK IN THE SYRINGE AND PLUNGER ROD DIFFICULT TO MOV. LOT # 7072979, PRODUCT # 328280, NO EXPIRATION DATE. OCCURRENCE DATE IS UNKNOWN. SENDING PRODUCT VOUCHER TO CONSUMER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 BD ULTRA-FINE NEEDLE INSULIN SYRINGE PLUNGER IS DIFFICULT TO MOVE AND THERE IS A CRACK IN THE SYRINGE BARREL. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. (B)(4), BATCH NO. 7072979. IT WAS REPORTED THAT PLUNGER IS DIFFICULT TO MOVE AND THERE IS A CRACK IN THE BARREL OF THE SYRINGE. VERBATIM: RECEIVED LETTER AND SAMPLE FROM CONSUMER REPORTING A CRACK IN THE SYRINGE AND PLUNGER ROD DIFFICULT TO MOVE (LETTER ATTACHED). LOT # 7072979, PRODUCT # 328280, NO EXPIRATION DATE. OCCURRENCE DATE IS UNKNOWN. SENDING PRODUCT VOUCHER TO CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331271 BD ULTRA-FINE NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7072979 00382903282807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other