BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿3 NEEDLES 30 G

    MDR report key: 16731837 · Received April 13, 2023

    Report

    Report Number
    3002682307-2023-00097
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 23, 2023
    Report Date
    July 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 220603, D4. MEDICAL DEVICE EXPIRATION DATE: 31MAY2027, H4. DEVICE MANUFACTURE DATE: 01JUN2022. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBERS 220603 AND 220609. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR INVESTIGATIVE TEAM. THROUGH EXAMINATION OF THE PICTURES, THE BLISTER PACKAGES WERE OBSERVED WITH RIPPED PAPER; HOWEVER, NO ABNORMALITIES WITH THE PERFORATION COULD BE IDENTIFIED THROUGH THE PICTURES. TWENTY (20) RETAINED SAMPLES OF THE SAME LOT NUMBERS WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER REVIEW. THE PERFORATED CUTTING OF THE RETAINED SAMPLES WAS FOUND TO BE WITHIN SPECIFICATIONS AND THE STRIPS COULD BE SEPARATED WITHOUT ISSUE. BASED ON THE PROVIDED FEEDBACK, WE UNDERSTAND THAT AN ISSUE RELATED TO DEFECTIVE PACKAGE CUTTING COULD HAVE TAKEN PLACE; HOWEVER, AT THIS TIME AN EXACT MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLES 30 G THE SEAL WAS DAMAGED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SMALL 30G 1/2 NEEDLES ARE NORMALLY RECEIVED IN INDIVIDUAL BLISTER PACKS ATTACHED BY 5 WITH PINS. IT IS BEFORE USE THAT WE MANUALLY SEPARATE EACH NEEDLE. BUT RECENTLY, WE NOTICED THAT WE HAD TEARS IN THE BLISTER AFTER SEPARATION; A PROBLEM THAT HAD NEVER BEEN OBSERVED BEFORE. THE TEARS ARE MORE OR LESS IMPORTANT BUT CAN CAST DOUBT ON THE INTEGRITY AND COMPROMISE IT. THIS PROBLEM HAS BEEN OBSERVED ON INTERNAL BATCH 220600734 AS WELL AS OTHER BATCHES SUCH AS 220700126.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLES 30 G THE SEAL WAS DAMAGED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SMALL 30G 1/2 NEEDLES ARE NORMALLY RECEIVED IN INDIVIDUAL BLISTER PACKS ATTACHED BY 5 WITH PINS. IT IS BEFORE USE THAT WE MANUALLY SEPARATE EACH NEEDLE. BUT RECENTLY, WE NOTICED THAT WE HAD TEARS IN THE BLISTER AFTER SEPARATION; A PROBLEM THAT HAD NEVER BEEN OBSERVED BEFORE. THE TEARS ARE MORE OR LESS IMPORTANT BUT CAN CAST DOUBT ON THE INTEGRITY AND COMPROMISE IT. THIS PROBLEM HAS BEEN OBSERVED ON INTERNAL BATCH 220600734 AS WELL AS OTHER BATCHES SUCH AS 220700126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992450 BD MICROLANCE¿3 NEEDLES 30 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220609 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown