BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA

    MDR report key: 11693208 · Received April 20, 2021

    Report

    Report Number
    1920898-2021-00432
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0083432. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA HAD STERILITY ISSUES. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS THINKING THAT THE SYRINGES THAT COME WITH THE STOPPER OUT OF THE LEVEL ZERO ARE NOT STERILIZED, COMMENTS THAT SHE IS INDIGNANT WITH THAT AND DEMANDS A RESPONSE. IT WAS TRIED TO EXPLAIN THAT THE SPACE CAN HAPPEN IN SOME SYRINGES DURING THE MANUFACTURING, AND THAT IT DOES NOT HAVE ANY RELATION WITH THE STERILITY OF THE PRODUCT, BUT SHE INSISTS IN BELIEVING THAT IT CANNOT HAVE THAT DIFFERENCE BETWEEN THE SYRINGES, SHE BELIEVES THAT THEY ALL SHOULD SEEM THE SAME, WITHOUT RESIDUAL SPACE. THE CUSTOMER FURTHER REPORTS THAT 3 SYRINGES ARE WITH VACUUM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED; THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. THIS IS THE 1ST RELATED COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. INVESTIGATION CONCLUSION: 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. RATIONALE: THE REPORTED ISSUE WAS OBSERVED AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. CORRECTIVE/PREVENTATIVE ACTION (CAPA) HAS BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA HAD STERILITY ISSUES. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS THINKING THAT THE SYRINGES THAT COME WITH THE STOPPER OUT OF THE LEVEL ZERO ARE NOT STERILIZED, COMMENTS THAT SHE IS INDIGNANT WITH THAT AND DEMANDS A RESPONSE. IT WAS TRIED TO EXPLAIN THAT THE SPACE CAN HAPPEN IN SOME SYRINGES DURING THE MANUFACTURING, AND THAT IT DOES NOT HAVE ANY RELATION WITH THE STERILITY OF THE PRODUCT, BUT SHE INSISTS IN BELIEVING THAT IT CANNOT HAVE THAT DIFFERENCE BETWEEN THE SYRINGES, SHE BELIEVES THAT THEY ALL SHOULD SEEM THE SAME, WITHOUT RESIDUAL SPACE. THE CUSTOMER FURTHER REPORTS THAT 3 SYRINGES ARE WITH VACUUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594701 SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA SYRINGE FMF BD MEDICAL - DIABETES CARE 0083432

    Patients

    Seq Age Sex Outcome Treatment
    1