BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10519357 · Received September 11, 2020

    Report

    Report Number
    1920898-2020-01199
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 8, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7079760, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2017-05-23. MEDICAL DEVICE LOT #: 6242667, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2016-10-20. MEDICAL DEVICE LOT #: 7107905, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2017-06-16. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(6), USA HAS BEEN USED AS A DEFAULT.  (B)(4). INVESTIGATION SUMMARY: LEVEL B 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 LABEL INFORMATION MISSING (EXPIRATION DATE) ON LOT(S) # 7079760, 6242667 AND 7107905. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 14 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, LABEL INFORMATION MISSING (EXPIRATION DATE) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED 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# 7079760. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200690794] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THIS BATCH WAS MANUFACTURED BEFORE EXPIRATION DATES WERE PRINTED ON PACKAGING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6242667. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THIS BATCH WAS MANUFACTURED BEFORE EXPIRATION DATES WERE PRINTED ON PACKAGING. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7107905. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THIS BATCH WAS MANUFACTURED BEFORE EXPIRATION DATES WERE PRINTED ON PACKAGING. 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 FAILURE 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 ISSUE IS 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 AN UNSPECIFIED NUMBER OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328466, BATCH NO: 7079760, 6242667, 7107905. COMPLAINT 2 OF 2. VERBATIM: PHARMACIST CALLED STATING SHE HAS 6 BOXES OF INSULIN SYRINGES WITH NO EXPIRATION DATE. STATED 5 BOXES HAVE THE SAME CAT # STATED ALL 6 BOXES HAVE A TRADEMARK DATE OF 2013. INFORMED THAT BD PRODUCTS ARE TESTED FOR 5 YEARS BEFORE THEY EXPIRE CAT # 328466, LOT # 7079760, LOT # 6242667, LOT # 7107905 ( THIS LOT # IS ON 3 BOXES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990048 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328466 SEE H10 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other