BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 12.7MM (1/2") 30G

    MDR report key: 15310913 · Received August 29, 2022

    Report

    Report Number
    9616656-2022-00920
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 4, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMF
    UDI-DI
    00382903282784
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 7241673 FOR LABEL INFORMATION MISSING (EXPIRATION DATE). THIS IS THE 1ST RELATED COMPLAINT FOR LABEL INFORMATION MISSING (EXPIRATION DATE) ON LOT # 7241673. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 15 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, LABEL INFORMATION MISSING) 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. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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# 7241673. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE ZERO NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. EXPIRATION DATES WERE NOT PRINTED ON PACKAGING UNTIL (B)(6) 2017. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 12.7MM (1/2") 30G THERE WAS MISSING LABEL INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE PHARMACIST THAT EXPIRATION DATE WAS MISSING FROM SHELF CARTON. PHARMACIST STATED SHE COULD NOT LOCATE THE EXPIRATION DATE AND WANTED TO KNOW IF SYRINGES EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101834 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 12.7MM (1/2") 30G PISTON SYRINGE FMF BECTON DICKINSON AND CO. 328278 7241673 00382903282784

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown