BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31G 6MM S/C U-100 RELION

    MDR report key: 9505757 · Received December 20, 2019

    Report

    Report Number
    1920898-2019-01458
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    November 25, 2019
    Report Date
    January 15, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) USED 31GX6MM, 1ML INSULIN SYRINGE. CONSUMER REPORTED INSULIN WAS NOT DISPENSED DURING THE INJECTION. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE SYRINGE WAS FILLED WITH MEDICATION, AND THE CANNULA WAS BLOCKED; THIS SYRINGE WAS NOT ABLE TO EXPEL THE PRE-FILLED CONTENTS. NO MANUFACTURING DEFECT ON THE SYRINGE WAS OBSERVED. SINCE THE SYRINGE WAS RETURNED AFTER USE, THE PROBABLE CAUSE OF THE CLOG IS USER ERROR: PRE-FILLING AND STORING INSULIN IN THE SYRINGE COULD LEAD TO INSULIN RESIDUE (CRYSTALLIZATION) CLOGGING THE CANNULA. THIS IS SUPPORTED BY THE FACT THAT THE SYRINGE WAS INITIALLY ABLE TO DRAW INSULIN WHEN PRE-FILLING, THUS THE CLOG WAS CAUSED AFTER THE SYRINGE WAS FILLED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9133864. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF (B)(6) 2019 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 # 9133864. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED 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 NOW FLOW OCCURRED DURING USE WITH A SYRINGE 1.0ML 31G 6MM S/C U-100 RELION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "REPORTED INSULIN WAS NOT DISPENSED DURING THE INJECTION. 31G, SHORT NEEDLE 6MM, 1ML. SHE STATED NEEDLE BENT DURING INSERTING IN TO THE STOMACH IN THE PAST. IT HAPPENED WITHIN THE LAST SIX MONTH PERIOD. SHE REPORTED NEEDLE BROKE WHILE INSERTING IN TO HER STOMACH 3 TIMES AND NEEDLE BROKE 3 TIMES WHILE INSERTING IN TO VIAL WITHIN THE LAST 6 MONTHS PERIOD.SHE USES THE NEW SYRINGES FOR HER INJECTION. SHE VISUALLY TEST THE NEEDLE TO SEE IF IT IS STRAIGHT." 1 OF 2 COMPLAINTS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NOW FLOW OCCURRED DURING USE WITH A SYRINGE 1.0ML 31G 6MM S/C U-100 RELION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "REPORTED INSULIN WAS NOT DISPENSED DURING THE INJECTION. 31G, SHORT NEEDLE 6MM, 1ML. SHE STATED NEEDLE BENT DURING INSERTING IN TO THE STOMACH IN THE PAST. IT HAPPENED WITHIN THE LAST SIX MONTH PERIOD. SHE REPORTED NEEDLE BROKE WHILE INSERTING IN TO HER STOMACH 3 TIMES AND NEEDLE BROKE 3 TIMES WHILE INSERTING IN TO VIAL WITHIN THE LAST 6 MONTHS PERIOD. SHE USES THE NEW SYRINGES FOR HER INJECTION. SHE VISUALLY TEST THE NEEDLE TO SEE IF IT IS STRAIGHT." 1 OF 2 COMPLAINTS.

    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 NOW FLOW OCCURRED DURING USE WITH A SYRINGE 1.0ML 31G 6MM S/C U-100 RELION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "REPORTED INSULIN WAS NOT DISPENSED DURING THE INJECTION. 31G, SHORT NEEDLE 6MM, 1ML. SHE STATED NEEDLE BENT DURING INSERTING IN TO THE STOMACH IN THE PAST. IT HAPPENED WITHIN THE LAST SIX MONTH PERIOD. SHE REPORTED NEEDLE BROKE WHILE INSERTING IN TO HER STOMACH 3 TIMES AND NEEDLE BROKE 3 TIMES WHILE INSERTING IN TO VIAL WITHIN THE LAST 6 MONTHS PERIOD. SHE USES THE NEW SYRINGES FOR HER INJECTION. SHE VISUALLY TEST THE NEEDLE TO SEE IF IT IS STRAIGHT." 1 OF 2 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302728 SYRINGE 1.0ML 31G 6MM S/C U-100 RELION PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328519 9133864 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other