BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8452943 · Received March 26, 2019

    Report

    Report Number
    1920898-2019-00281
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 11, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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 # 6221849 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) 0.3ML, 6MM X 31G SHELF CARTON SIDE FROM CAT # 324910 AND LOT # 6221849, (2) OPENED POLYBAGS FROM CAT # 324909 AND LOT # 7023686, AND (1) OPENED POLYBAG FROM CAT # 324910 AND LOT # 7023681. SPOUSE OF CONSUMER REPORTED MIXED PRODUCT IN BOX, RECEIVED BOX OF 6MM SYRINGES THAT SHOULD HAVE 1/2 UNIT MARKINGS. ONE OF THE TWO LAST BAGS IN THE BOX IS WHOLE UNIT WITH LOT # 702656 AND PRODUCT # 324909, THE OTHER BAG IS HALF UNIT WITH LOT # 7023651 AND PRODUCT # 324910. THE LOT # ON BOX IS 6221849, PRODUCT # 324910. ALL RETURNED SAMPLES WERE EXAMINED AND IT WAS OBSERVED THAT THE SHELF CARTON WITH THE ALLEGED DEFECT, AS WELL AS ALL (3) POLYBAGS, WERE RETURNED OPENED. THE LOT NUMBER ON THE SHELF CARTON DID NOT MATCH UP WITH THE LOT NUMBERS OF THE RETURNED POLYBAGS, HOWEVER, SINCE ALL 4 ITEMS WERE RETURNED OPENED (UNSEALED) THE ALLEGED DEFECT (MIXED CATALOG NUMBERS) COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 6221849 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOX OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES CONTAINED A BAG OF CATALOG # 324909, LOT # 702656 PRODUCT IN IT, WHILE ANOTHER BAG HAD HALF OF THE SAME CATALOG # 324910 IN IT AS THE LABELED BOX, BUT A DIFFERENT LOT #, WHICH WAS 7023651 IN THE BAG AND 6221849 LABELED ON THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE OF CONSUMER REPORTED MIXED PRODUCT IN BOX, RECEIVED BOX OF 6MM SYRINGES THAT SHOULD HAVE 1/2 UNIT MARKINGS. ONE OF THE TWO LAST BAGS IN THE BOX IS WHOLE UNIT WITH LOT # 702656 AND PRODUCT # 324909, THE OTHER BAG IS HALF UNIT WITH LOT # 7023651 AND PRODUCT # 324910. THE LOT # ON BOX IS 6221849, PRODUCT # 324910. CONSUMER RECEIVES A THREE MONTH SUPPLY FROM THE PHARMACY. STATED THAT SYRINGES ARE KEPT IN BOX UNTIL READY FOR USE AND DOES NOT RE-USE. CONSUMER NOTICED THE PROBLEM TODAY, 03-11-19. WILL SEND SAMPLES AND POLY BAG. SENDING MAIL KIT AND PRODUCT VOUCHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOX OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES CONTAINED A BAG OF CATALOG # 324909, LOT # 702656 PRODUCT IN IT, WHILE ANOTHER BAG HAD HALF OF THE SAME CATALOG # 324910 IN IT AS THE LABELED BOX, BUT A DIFFERENT LOT #, WHICH WAS 7023651 IN THE BAG AND 6221849 LABELED ON THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE OF CONSUMER REPORTED MIXED PRODUCT IN BOX, RECEIVED BOX OF 6MM SYRINGES THAT SHOULD HAVE 1/2 UNIT MARKINGS. ONE OF THE TWO LAST BAGS IN THE BOX IS WHOLE UNIT WITH LOT # 702656 AND PRODUCT # 324909, THE OTHER BAG IS HALF UNIT WITH LOT # 7023651 AND PRODUCT # 324910. THE LOT # ON BOX IS 6221849, PRODUCT # 324910. CONSUMER RECEIVES A THREE MONTH SUPPLY FROM WALMART PHARMACY, 3801 RUNNING BROOK FARMS BLVD, JOHNSBURG IL60057. STATED THAT SYRINGES ARE KEPT IN BOX UNTIL READY FOR USE AND DOES NOT RE-USE. CONSUMER NOTICED THE PROBLEM TODAY, 03-11-19. WILL SEND SAMPLES AND POLY BAG. SENDING MAIL KIT AND PRODUCT VOUCHER."

    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 #: 6221849, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2016-10-03; MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOX OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES CONTAINED A BAG OF CATALOG # 324909, LOT # 702656 PRODUCT IN IT, WHILE ANOTHER BAG HAD HALF OF THE SAME CATALOG # 324910 IN IT AS THE LABELED BOX, BUT A DIFFERENT LOT #, WHICH WAS 7023651 IN THE BAG AND 6221849 LABELED ON THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE OF CONSUMER REPORTED MIXED PRODUCT IN BOX, RECEIVED BOX OF 6MM SYRINGES THAT SHOULD HAVE 1/2 UNIT MARKINGS. ONE OF THE TWO LAST BAGS IN THE BOX IS WHOLE UNIT WITH LOT # 702656 AND PRODUCT # 324909, THE OTHER BAG IS HALF UNIT WITH LOT # 7023651 AND PRODUCT # 324910. THE LOT # ON BOX IS 6221849, PRODUCT # 324910. CONSUMER RECEIVES A THREE MONTH SUPPLY FROM (B)(6). STATED THAT SYRINGES ARE KEPT IN BOX UNTIL READY FOR USE AND DOES NOT RE-USE. CONSUMER NOTICED THE PROBLEM TODAY, (B)(6) 2019. WILL SEND SAMPLES AND POLY BAG. SENDING MAIL KIT AND PRODUCT VOUCHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246255 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE SECTION H.10. 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other