BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN BLS 500 SL

    MDR report key: 9318533 · Received November 13, 2019

    Report

    Report Number
    1920898-2019-01287
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 14, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    K944757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 4 DECEMBER 2019 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. UNABLE TO PERFORM A DHR REVIEW DUE TO AN UNKNOWN LOT NUMBER.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/3/2020. D.4. MEDICAL DEVICE LOT #: 7018751. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 3/20/2007. D.4. MEDICAL DEVICE LOT #: 7353533. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 2/7/2008. D.4. MEDICAL DEVICE LOT #: 5014868. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 5/14/2015. H.6. INVESTIGATION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE (DIFFICULT TO READ LINES THROUGH SLEEVE) ON LOT(S) # 7018751, 7353533 AND 5014868. CUSTOMER RETURNED (5) 1ML, 13MM, 29G BD SAFETY-LOK SYRINGES IN SEALED BLISTER PACKS FROM LOT # 5014868, (1) 1ML, 13MM, 29G BD SAFETY-LOK SYRINGE IN A SEALED BLISTER PACK FROM LOT # 7018751, AND (2) 1ML, 13MM, 29G BD SAFETY-LOK SYRINGES IN SEALED BLISTER PACKS FROM LOT # 7353533. CUSTOMER STATES THAT THEY CANNOT READ THE LINES ON THE SYRINGES BECAUSE OF THE "SAFETY LOK SLEEVE". ALL RETURNED SYRINGES WERE EXAMINED AND ALL SCALE MARKINGS WERE CLEARLY VISIBLE PRINTED ON THE BARRELS OF THE SYRINGES. NO DEFECTS WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #5014868. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. FOR LOT # 7018751, DUE TO BATCH BEING MANUFACTURED IN 2007 AND DHR FILES ARE RETAINED FOR 7 YEARS, NO DHR CAN BE REVIEWED. FOR LOT # 7353533, DUE TO BATCH BEING MANUFACTURED IN 2008 AND DHR FILES ARE RETAINED FOR 7 YEARS, NO DHR CAN BE REVIEWED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 1.0ML 29GA 1/2IN BLS 500 SL HAS BEEN FOUND EXPERIENCING 100 OCCURRENCES OF SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329464 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE CUSTOMER CANNOT READ THE LINES ON THE SYRINGES BECAUSE OF THE "SAFETY LOK SLEEVE" . VERBATIM: CONSUMER STATED, SHE CANNOT READ THE LINES ON THE SYRINGES BECAUSE OF THE "SAFETY LOK SLEEVE" . STATED, WHEN SHE WAS YOUNGER, SHE HAD NO PROBLEM BUT NOW THAT SHE'S OLDER, ITS HARD TO SEE THE LINES THROUGH THAT "SLEEVE" HAS NOT USE THEM FOR HER INJECTIONS, SHE PURCHASED SOMETHING ELSE CONSUMER STILL HAS OVER 100 SYRINGES THAT SHE WILL NOT BE USING, SHE WANTS TO REPLACE THEM WITH SOMETHING ELSE. ITEM: 329464 COULD NOT PROVIDE A LOT OR EXPIRATION DATE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 1.0ML 29GA 1/2IN BLS 500 SL HAS BEEN FOUND EXPERIENCING 100 OCCURRENCES OF SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329464 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE CUSTOMER CANNOT READ THE LINES ON THE SYRINGES BECAUSE OF THE "SAFETY LOK SLEEVE." VERBATIM: CONSUMER STATED, SHE CANNOT READ THE LINES ON THE SYRINGES BECAUSE OF THE "SAFETY LOK SLEEVE." STATED, WHEN SHE WAS YOUNGER, SHE HAD NO PROBLEM BUT NOW THAT SHE'S OLDER, ITS HARD TO SEE THE LINES THROUGH THAT "SLEEVE" HAS NOT USE THEM FOR HER INJECTIONS, SHE PURCHASED SOMETHING ELSE CONSUMER STILL HAS OVER 100 SYRINGES THAT SHE WILL NOT BE USING, SHE WANTS TO REPLACE THEM WITH SOMETHING ELSE. ITEM: 329464. COULD NOT PROVIDE A LOT OR EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE 1.0ML 29GA 1/2IN BLS 500 SL HAS BEEN FOUND EXPERIENCING 100 OCCURRENCES OF SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329464 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE CUSTOMER CANNOT READ THE LINES ON THE SYRINGES BECAUSE OF THE "SAFETY LOK SLEEVE". VERBATIM: CONSUMER STATED, SHE CANNOT READ THE LINES ON THE SYRINGES BECAUSE OF THE "SAFETY LOK SLEEVE". STATED, WHEN SHE WAS YOUNGER, SHE HAD NO PROBLEM BUT NOW THAT SHE'S OLDER, ITS HARD TO SEE THE LINES THROUGH THAT "SLEEVE" HAS NOT USE THEM FOR HER INJECTIONS, SHE PURCHASED SOMETHING ELSE CONSUMER STILL HAS OVER 100 SYRINGES THAT SHE WILL NOT BE USING, SHE WANTS TO REPLACE THEM WITH SOMETHING ELSE. ITEM: 329464. COULD NOT PROVIDE A LOT OR EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108418 SYRINGE 1.0ML 29GA 1/2IN BLS 500 SL NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other