BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM

    MDR report key: 9857215 · Received March 19, 2020

    Report

    Report Number
    1920898-2020-00280
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 28, 2020
    Report Date
    April 6, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311748
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (13) LOOSE 1CC, 8MM SYRINGES. CUSTOMER STATES THAT THEY ARE FINDING LITTLE PIECES OF PLASTIC IN THE SYRINGES. ALL RETURNED SYRINGES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED IN OR ON ANY OF THE RETURNED SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9182251. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND DURING USE WITH A SYRINGE 1.0ML 31GA 8MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THIS RECORD CAPTURES ISSUES THAT OCCURRED ON UNKNOWN DATE AND THOSE THAT OCCURRED ON (B)(6) 2020. IT WAS REPORTED THAT THE CUSTOMER WAS FINDING PIECES OF PLASTIC INSIDE SYRINGES VERBATIM: CALLER STATED, SHE WAS CALLING ON BEHALF OF HER CLIENT AND ASSISTING HIM. STATED, THE CONSUMER IS FINDING "LITTLE PIECES OF PLASTIC" IN SYRINGES STATED, THE SYRINGES WERE NOT USED IF PLASTIC IS FOUND IN THEM STATED, DID NOT WANT TO GIVE HER PERSONAL INFORMATION BUT WANTED TO PROVIDE, THE CONSUMERS INFORMATION. CALLER ASKED, WHY HER PERSONAL INFORMATION WAS NEEDED. EXPLAINED, THAT IS A PRIVACY ISSUE AND I WOULD NEED TO SPEAK WITH THE CONSUMER CAME TO PHONE AND STATED: THIS MORNING, HE FOUND IN ONE SYRINGE, 15 PIECES OF PLASTIC IN A SECOND SYRINGE, HE FOUND 3 PIECES OF PLASTIC STATED, IT COULD "RESULT IN A DEATH" STATED, NEXT TIME THERE WOULD BE A LAWYER INVOLVED STATED, THE SYRINGES WERE SITTING ON SHELF TOO LONG AND THAT'S WHY THEY'RE BREAKING DOWN. LOT: 9182251 CATALOG: 31G, 8MM, 1ML INCIDENT DATE: (B)(6) 2020 (2 SYRINGES AFFECTED)." 2 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: N/A. 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 FOREIGN MATTER WAS FOUND DURING USE WITH A SYRINGE 1.0ML 31GA 8MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THIS RECORD CAPTURES ISSUES THAT OCCURRED ON UNKNOWN DATE AND THOSE THAT OCCURRED ON (B)(6) 2020. IT WAS REPORTED THAT THE CUSTOMER WAS FINDING PIECES OF PLASTIC INSIDE SYRINGES. VERBATIM: CALLER STATED, SHE WAS CALLING ON BEHALF OF HER CLIENT AND ASSISTING HIM. STATED, THE CONSUMER IS FINDING "LITTLE PIECES OF PLASTIC" IN SYRINGES. STATED, THE SYRINGES WERE NOT USED IF PLASTIC IS FOUND IN THEM. STATED, DID NOT WANT TO GIVE HER PERSONAL INFORMATION BUT WANTED TO PROVIDE, THE CONSUMERS INFORMATION. CALLER ASKED, WHY HER PERSONAL INFORMATION WAS NEEDED. EXPLAINED, THAT IS A PRIVACY ISSUE AND I WOULD NEED TO SPEAK WITH THE CONSUMER CAME TO PHONE AND STATED: THIS MORNING, HE FOUND IN ONE SYRINGE, 15 PIECES OF PLASTIC. IN A SECOND SYRINGE, HE FOUND 3 PIECES OF PLASTIC. STATED, IT COULD "RESULT IN A DEATH". STATED, NEXT TIME THERE WOULD BE A LAWYER INVOLVED. STATED, THE SYRINGES WERE SITTING ON SHELF TOO LONG AND THAT'S WHY THEY'RE BREAKING DOWN. LOT: 9182251, CATALOG: 31G, 8MM, 1ML, INCIDENT DATE: (B)(6) 2020, (2 SYRINGES AFFECTED)." 2 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321309 SYRINGE 1.0ML 31GA 8MM INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 328506 9182251 00681131311748

    Patients

    Seq Age Sex Outcome Treatment
    1 Other