BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSULIN SYRINGE

    MDR report key: 8387972 · Received March 4, 2019

    Report

    Report Number
    1920898-2019-00222
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 15, 2019
    Report Date
    March 13, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00311917025278
    PMA / PMN Number
    K955235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8121963 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ INSULIN SYRINGE HAD FLUID IN THE SYRINGES AND THE SYRINGES LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO.: 928855, BATCH NO.: 8121963. IT WAS REPORTED BY THE CONSUMER THAT THERE WAS FLUID IN THE SYRINGES AND THE SYRINGES LEAKED. VERBATIM: CONSUMER REPORTED FLUID IN SYRINGES, STATED THAT THE SYRINGES LEAKED. CONSUMER PROVIDED LOT # 8121963, 30G, 3/10ML, 8MM (PRODUCT # 928855). SHE WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION, STATED THAT HER ATTORNEY ADVISED HER NOT TO GIVE ANY INFORMATION. SHE CALLED FOR MAILING ADDRESS TO SEND SYRINGES FOR TESTING. I ADVISED HER TO HAVE HER ATTORNEY CONTACT US."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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¿ INSULIN SYRINGE HAD FLUID IN THE SYRINGES AND THE SYRINGES LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO.: 928855, BATCH NO.: 8121963. IT WAS REPORTED BY THE CONSUMER THAT THERE WAS FLUID IN THE SYRINGES AND THE SYRINGES LEAKED. VERBATIM: CONSUMER REPORTED FLUID IN SYRINGES, STATED THAT THE SYRINGES LEAKED. CONSUMER PROVIDED LOT # 8121963, 30G, 3/10ML, 8MM (PRODUCT # 928855). SHE WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION, STATED THAT HER ATTORNEY ADVISED HER NOT TO GIVE ANY INFORMATION. SHE CALLED FOR MAILING ADDRESS TO SEND SYRINGES FOR TESTING. I ADVISED HER TO HAVE HER ATTORNEY CONTACT US".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180254 BD¿ INSULIN SYRINGE HYPODERMIC NEEDLE FMI BD MEDICAL - DIABETES CARE 8121963 00311917025278

    Patients

    Seq Age Sex Outcome Treatment
    1 Other