BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 13667981 · Received March 4, 2022

    Report

    Report Number
    1920898-2022-00143
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 18, 2022
    Report Date
    April 29, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 : LOT # : 0041675 : DEVICE EXPIRATION DATE : 02/28/2025; DEVICE MANUFACTURE DATE : 02/10/2020. LOT # : 1081661: DEVICE EXPIRATION DATE : 03/31/2026, DEVICE MANUFACTURE DATE : 03/22/2021. LOT # : 0017422: DEVICE EXPIRATION DATE : 01/31/2025, DEVICE MANUFACTURE DATE : 01/17/2020. LOT # : 0209167: DEVICE EXPIRATION DATE : 08/31/2025, DEVICE MANUFACTURE DATE : 07/27/2020. LOT # : 1200845: DEVICE EXPIRATION DATE : 07/31/2026, DEVICE MANUFACTURE DATE : 07/19/2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUTION ?: YES D.9. RETURNED TO MANUFACTURER ON: 07-MAR-2022 H.6. INVESTIGATION: CUSTOMER RETURNED A TOTAL OF (49) 1ML, 31 GAUGE, 8MM, SYRINGES ALONGSIDE 5 POLYBAGS. THE POLYBAGS SHOW THAT 2 ARE FROM LOT 0209167, 1 IS FROM LOT 1081661, AND 2 FROM LOT 1200845. NO POLYBAGS FROM REPORTED LOTS 0041675 OR 0017422 WERE RETURNED. ALL POLYBAGS WERE RETURNED OPENED. APPROXIMATELY 28 OR THE 49 SAMPLES RETURNED FEATURED SOME DEGREE OF BENDING/BOWING TO THE BARREL OF THE SYRINGE. THIS APPEARS TO HAVE TRANSLATED TO THE NEEDLE HUB AND ITS CHANNEL AS WELL, ALLOWING THE HUB AND NEEDLE TO BE SKEWED AT AN ANGLE IN THESE INSTANCES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0017422. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0209167. 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# 1200845. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR BARREL BOWED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0041675. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1081661. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE BARRELS BEING BOWED. PROBABLE ROOT CAUSE: ¿ DMHS ON THE MAGNET SET WAS TOO HIGH. ¿ PULLING CANNULA TOO FAR TO ONE SIDE. ¿ CARRIER WASN'T LINED UP CORRECTLY. ¿ 0.30 SECONDS OUT OF ALIGNMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 22 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD DAMAGED PRODUCT ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER STATED THAT THE BODY OF THE SYRINGE IS CURVED PRIOR TO USE AND WHEN THE NEEDLE SHIELD IS REMOVED THE HUB IS NOT CENTERED AND NEEDLE IS CROOKED. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE - SYRINGES HAVE NOT BEEN USED AND HAS OVER 200 SYRINGES TO RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 22 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD DAMAGED PRODUCT ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER STATED THAT THE BODY OF THE SYRINGE IS CURVED PRIOR TO USE AND WHEN THE NEEDLE SHIELD IS REMOVED THE HUB IS NOT CENTERED AND NEEDLE IS CROOKED. DATE OF EVENT : UNKNOWN SAMPLES : AVAILABLE - SYRINGES HAVE NOT BEEN USED AND HAS OVER 200 SYRINGES TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532962 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown