BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 8516521 · Received April 15, 2019

    Report

    Report Number
    1920898-2019-00351
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 29, 2019
    Report Date
    April 18, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL: YES. RETURNED TO MANUFACTURER ON: 2019-04-17. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVAL BY MANUFACTURER: YES. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR THUMBPRESS MISSING AND EXCESS (PLUNGER CAP) ON LOT # 8043581. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 0.5ML, 6MM, 31G BD INSULIN SYRINGE ASSEMBLY AND (1) LOOSE PLUNGER CAP. CONSUMER REPORTED FOUND 1 SYRINGE WITHOUT A THUMB PRESS ON THE SYRINGE, WHEN REMOVED FROM THE BAG, ALSO FOUND EXTRA PLUNGER CAP LAYING IN THE BAG. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN PLUNGER ROD AND CRUSHED PLUNGER CAP. THE EXCESS PLUNGER CAP ISSUE COULD NOT BE CONFIRMED AS NO MANUFACTURING DEFECT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8043581. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. SAMPLE WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) ON 19 APRIL 2019 FOR FURTHER REVIEW. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES (BROKEN PLUNGER ROD, DAMAGED PLUNGER CAP). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (EXCESS PLUNGER CAP). 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. ROOT CAUSE DESCRIPTION: POSSIBLE ROOT CAUSE: THE SYRINGE WAS CAUGHT IN THE SEALING BARS OF THE PACKAGING MACHINE, CRUSHING THE CAP AND BREAKING THE PLUNGER. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE (EXCESS PLUNGER CAP) IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE WAS MISSING THE THUMB PRESS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324911 BATCH NO. 8043581. IT WAS REPORTED THAT 1 SYRINGE HAD NO THUMB PRESS AND THERE WAS AN EXTRA PLUNGER CAP LOOSE IN THE POLYBAG. VERBATIM: ITEM # 324911 LOT# 8043581 A EXP 2023-02-28 FOUND 1 SYRINGE WITHOUT A THUMB PRESS ON THE SYRINGE, WHEN REMOVED FROM THE BAG. ALSO FOUND EXTRA PLUNGER CAP LAYING IN THE BAG.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR THUMB PRESS MISSING AND EXCESS (PLUNGER CAP) ON LOT # 8043581. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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# 8043581. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: 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 FAILURES AS NO SAMPLES OR PHOTOS WERE RETURNED. 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUES ARE UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE WAS MISSING THE THUMB PRESS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324911, BATCH NO. 8043581. IT WAS REPORTED THAT 1 SYRINGE HAD NO THUMB PRESS AND THERE WAS AN EXTRA PLUNGER CAP LOOSE IN THE POLYBAG. VERBATIM: ITEM # 324911, LOT# 8043581, A EXP 2023-02-28 FOUND 1 SYRINGE WITHOUT A THUMB PRESS ON THE SYRINGE, WHEN REMOVED FROM THE BAG. ALSO FOUND EXTRA PLUNGER CAP LAYING IN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309719 BD ULTRA-FINE INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 8043581 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other