BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE

    MDR report key: 13256399 · Received January 13, 2022

    Report

    Report Number
    1920898-2021-01402
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 16, 2021
    Report Date
    January 20, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903294084
    PMA / PMN Number
    K010890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8253834; MEDICAL DEVICE EXPIRATION DATE: 2023-09-30; DEVICE MANUFACTURE DATE: 2018-09-10. MEDICAL DEVICE LOT #: 9098718; MEDICAL DEVICE EXPIRATION DATE: 2024-07-31; DEVICE MANUFACTURE DATE: 2019-04-08. MEDICAL DEVICE LOT #: 9343440; MEDICAL DEVICE EXPIRATION DATE: 2024-12-31; DEVICE MANUFACTURE DATE: 2019-12-09. MEDICAL DEVICE LOT #: UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 6347519; MEDICAL DEVICE EXPIRATION DATE: NA; DEVICE MANUFACTURE DATE: 2016-02-17. MEDICAL DEVICE LOT #: 9042896; MEDICAL DEVICE EXPIRATION DATE: 2024-02-29; DEVICE MANUFACTURE DATE: 2019-02-11. MEDICAL DEVICE LOT #: 1144233; MEDICAL DEVICE EXPIRATION DATE: 2026-06-30; DEVICE MANUFACTURE DATE: 2021-05-24.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. CUSTOMER RETURNED (3) 1/2CC, 8MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 1144233. CUSTOMER STATES THAT THE BARRELS ARE CRACKED. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED CRACKS IN THE BARREL RUNNING FROM THE 45 UNIT MARKING TO THE FLANGE. CUSTOMER RETURNED (1) 1/2CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 9042896. CUSTOMER STATES THAT THE SYRINGE LEAKED MEDICATION. THE RETURNED SYRINGE WAS TESTED AND WAS ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. USTOMER RETURNED (1) 1/2CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 6347519. CUSTOMER STATES THAT THEY COULD NOT PULL PLUNGER OUT OF SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A DEFORMED PLUNGER ROD. CUSTOMER RETURNED (1) LOOSE 1/2CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 8253834. CUSTOMER STATES THAT THERE WAS A RED SUBSTANCE IN THE BARREL OF SYRINGES. THE RETURNED SYRINGE WAS EXAMINED AND NO FOREIGN MATTER WAS OBSERVED. HOWEVER, THE SAMPLE EXHIBITED AN AIR BUBBLE EMBEDDED IN THE PLASTIC OF THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1144233. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9042896. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6347519. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8253834. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SIX (6) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CRACKED BARREL). BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE SYRINGE LEAKED MEDICATION. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DEFORMED PLUNGER ROD). BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE AIR BUBBLE EMBEDDED IN THE PLASTIC OF THE BARREL. ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE, THE DEVICE EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA / IN FLUID PATH , PLUNGER MOVEMENT DIFFICULT, LEAKAGE, FAILURE OF PRODUCT TO CONTAIN MEDICATION (I.E. CRACK, HOLE, CUT, ETC.) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE WAS A RED SUBSTANCE IN THE BARREL OF SYRINGES. SYRINGES WERE MISSING NEEDLE. ONE SYRINGE COULD NOT PULL PLUNGER OUT OF SYRINGE. ALSO REPORTED ONE SYRINGE LEAKED MEDICATION. TWO SYRINGES HAD CRACKED BARRELS. CONSUMER REPORTED ON 1 SYRINGE FOUND RED SUBSTANCES IN THE BARREL OF SYRINGES.-LOT #: 8253834D. CONSUMER REPORTED FOUND 3 WITHOUT A NEEDLE WHEN REMOVED SHIELD, SHIELD REMOVAL WENT AS NORMAL .-LOT #: 9098718 - LOT # 9343440D & LOT # 8316615B. CONSUMER REPORTED FOUND 1 SYRINGE COULD NOT PULL PLUNGER OUT OF SYRINGE.-LOT #: 6347519A. CONSUMER REPORTED FOUND 1 SYRINGE MEDICATION LEAKED OUT THE TOP OF SYRINGE WHEN IN USE/ PLUNGER AREA.-LOT #: 9042896A. CONSUMER REPORTED CALLER FOUND 1 SYRINGE NEEDLE MISSING CONSUMER REPORTED FOUND 2 SYRINGES WITH CRACKED BARRELS LOT #: 1144233C.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE, THE DEVICE EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA / IN FLUID PATH , PLUNGER MOVEMENT DIFFICULT, LEAKAGE, FAILURE OF PRODUCT TO CONTAIN MEDICATION (I.E. CRACK, HOLE, CUT, ETC.) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE WAS A RED SUBSTANCE IN THE BARREL OF SYRINGES. SYRINGES WERE MISSING NEEDLE. ONE SYRINGE COULD NOT PULL PLUNGER OUT OF SYRINGE. ALSO REPORTED ONE SYRINGE LEAKED MEDICATION. TWO SYRINGES HAD CRACKED BARRELS. CONSUMER REPORTED ON 1 SYRINGE FOUND RED SUBSTANCES IN THE BARREL OF SYRINGES.-LOT #: 8253834D. CONSUMER REPORTED FOUND 3 WITHOUT A NEEDLE WHEN REMOVED SHIELD, SHIELD REMOVAL WENT AS NORMAL .-LOT #: 9098718 - LOT # 9343440D & LOT # 8316615B. CONSUMER REPORTED FOUND 1 SYRINGE COULD NOT PULL PLUNGER OUT OF SYRINGE.-LOT #: 6347519A. CONSUMER REPORTED FOUND 1 SYRINGE MEDICATION LEAKED OUT THE TOP OF SYRINGE WHEN IN USE/ PLUNGER AREA.-LOT #: 9042896A. CONSUMER REPORTED CALLER FOUND 1 SYRINGE NEEDLE MISSING . CONSUMER REPORTED FOUND 2 SYRINGES WITH CRACKED BARRELS. LOT #: 1144233C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902230 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 329408 SEE H.10. 00382903294084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown