BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN¿ SYRINGE

    MDR report key: 8016706 · Received October 29, 2018

    Report

    Report Number
    1920898-2018-00810
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 9, 2018
    Report Date
    November 16, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138369
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 1/2CC, 6MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 7072970. CUSTOMER STATES THAT THE SHIELD WAS BROKEN, THE NEEDLE WAS STICKING THROUGH THE BAG, THE NEEDLE WAS THROUGH SHIELD, AND THE NEEDLE TIP WAS BROKEN. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A BROKEN SHIELD WITH THE CANNULA BENT. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 02NOV2018 FOR FURTHER REVIEW. ON 05NOV2018, HOLDREGE RECEIVED TEN (10) 0.5ML, 6MM, 31G SYRINGES IN AN OPENED POLYBAG FROM BATCH # 7072970. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 AND HQA-68 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. THE DEFECTIVE RETURNED SAMPLE WAS VISUALLY INSPECTED AND NOTED THAT THE MAJORITY OF THE CANNULA SHIELD APPEARS TO HAVE BEEN TORN AWAY AND THE CANNULA BENT AT ROUGHLY A 90° ANGLE. ADDITIONALLY THE POLYBAG WAS VISUALLY INSPECTED AND NOTED DAMAGE AROUND THE REGISTRATION BOX (BLACK BOX USED FOR ALIGNMENT ON THE EQUIPMENT) AND WHAT APPEARS SIGNS OF TOO MUCH HEAT APPLIED. PROBABLE ROOT CAUSE IS LIKELY TO BE A JAW JAM ON THE FFS (FORM FILL & SEAL) EQUIPMENT DURING THE FORMATION AND FILLING OF THE POLYBAG WITH SYRINGES. WHEN THIS OCCURS, ANY PORTION OF THE SYRINGE OR COMPONENTS MAY BE INVOLVED IN THE JAM AND EXHIBIT VARYING DEGREES OF DAMAGE, SUCH AS THAT NOTED FROM THE RETURNED SAMPLE. GENERALLY, THE DAMAGE IS SUFFICIENT TO RENDER THE DEVICE INOPERABLE BY THE END-USER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7072970. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE SHIELD BROKEN, CANNULA THROUGH SHIELD, NEEDLE TIP BROKEN LOT # 7072970 BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN SHIELD, BENT CANNULA). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CANNULA THROUGH SHIELD). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN¿ SYRINGE HAD A BROKEN NEEDLE, THE NEEDLE PIERCED THE SAFETY SHIELD, AND THERE WAS A BREACH IN THE STERILE BARRIER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 A BROKEN NEEDLE, THE NEEDLE PIERCED THE SAFETY SHIELD, AND THERE WAS A BREACH IN THE STERILE BARRIER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855925 BD INSULIN¿ SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7072970 00681131138369

    Patients

    Seq Age Sex Outcome Treatment
    1 Other