BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 17568521 · Received August 17, 2023

    Report

    Report Number
    3002682307-2023-00253
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 27, 2023
    Report Date
    October 14, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 05-SEP-2023 H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4) AND LOT NUMBERS 230505, 230408, AND 230410. 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, FOUR (4) USED NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. ONE NEEDLE WAS RECEIVED IN AN UNPACKAGED BLISTER FOR LOT 230408, THE NEEDLE DISPLAYED CANNULA POINT DAMAGE. ANOTHER NEEDLE WAS WITHIN AN UNPACKAGED BLISTER FOR LOT 230410, THIS NEEDLE ALSO DISPLAYED CANNULA POINT DAMAGE. TWO NEEDLES WERE RECEIVED WITHOUT THEIR BLISTER PACKAGES; ONE WAS A SHORT BEVEL NEEDLE BELONGING TO MATERIAL (B)(4) AND THE SECOND NEEDLE WAS A REGULAR BEVEL NEEDLE BELONGING TO MATERIAL (B)(4). NO DEFECTS WERE OBSERVED WITH THE TWO UNPACKAGED NEEDLES. ALTHOUGH THE PROVIDED FEEDBACK INDICATES AN ISSUE OF CORING EFFECT, THE INVESTIGATION RESULTS DID NOT IDENTIFY ANY POTENTIAL MANUFACTURING RELATED CAUSE FOR SUCH AN EVENT. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. REGARDING THE REPORT OF ¿BEVEL BENT WHEN TRYING TO INJECT,¿ CANNULA POINT DAMAGE WAS IDENTIFIED WITH THE RETURNED SAMPLES. CANNULA POINT CONDITION IS REGULARLY DURING PRODUCTION AND A PENETRABILITY TEST IS PERFORMED FOR EACH LOT RELEASED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 230408 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2028 H.4. DEVICE MANUFACTURE DATE: 03-APR-2023 D.4. MEDICAL DEVICE LOT #: 230505 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2028 H.4. DEVICE MANUFACTURE DATE: 02-MAY-2023 H.3. 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 · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE CAUSED CORING IN THE 1L BAG OF G2.5% WHILE INJECTING POTASSIUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "2ND INCIDENT (B)(4) ON (B)(6) 2023 IN THE NEUROVASCULAR INTENSIVE CARE DEPARTMENT: AFTER PLANNING TO INJECT SUPPLEMENTS (POTASSIUM) INTO A 1L BAG OF G2.5%, THE TROCARD WAS BLOCKED BY THE GREY PLASTIC INTENDED FOR SAMPLING. I'VE DRILLED OUT THE PLASTIC WITH THE TROCARD, SO I'M RUNNING THE RISK OF REINJECTING THE PLASTIC INTO THE BAG, WITH THE RISK OF INJECTING IT INTO THE PATIENT WITHOUT SEEING HIM, GIVEN THE SMALL SIZE OF THE PIECE OF PLASTIC. BATCH NO. UNKNOWN (TWO BATCH NUMBERS AVAILABLE IN THE SERVICE: 230408 AND 230505) 3RD INCIDENT (B)(4) OCCURRED ON (B)(6) 2023 IN THE REANIMATION NEUROTRAUMATO DEPARTMENT: TROCARD WHOSE BEVEL BENT WHEN TRYING TO INJECT ACUPAN INTO A SALINE BAG. IN ADDITION, WE SOMETIMES HAVE DIFFICULTY SAMPLING WITH CERTAIN TROCARDS OF THIS REFERENCE, WHATEVER THE PRODUCT. THE TROCARD WAS USED CORRECTLY. CLINICAL CONSEQUENCES AND CURRENT STATE OF THE PATIENT OR PERSON INVOLVED: NOTHING TO REPORT ACTIONS TAKEN FOR THE PATIENT WITH REGARD TO THE DM: CHANGE OF DEVICES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE CAUSED CORING IN THE 1L BAG OF G2.5% WHILE INJECTING POTASSIUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "2ND INCIDENT D23-206 ON (B)(6) 2023 IN THE NEUROVASCULAR INTENSIVE CARE DEPARTMENT: AFTER PLANNING TO INJECT SUPPLEMENTS (POTASSIUM) INTO A 1L BAG OF G2.5%, THE TROCARD WAS BLOCKED BY THE GREY PLASTIC INTENDED FOR SAMPLING. I'VE DRILLED OUT THE PLASTIC WITH THE TROCARD, SO I'M RUNNING THE RISK OF REINJECTING THE PLASTIC INTO THE BAG, WITH THE RISK OF INJECTING IT INTO THE PATIENT WITHOUT SEEING HIM, GIVEN THE SMALL SIZE OF THE PIECE OF PLASTIC. BATCH NO. UNKNOWN (TWO BATCH NUMBERS AVAILABLE IN THE SERVICE: 230408 AND 230505) 3RD INCIDENT D23-211 OCCURRED ON (B)(6) 2023 IN THE REANIMATION NEUROTRAUMATO DEPARTMENT: TROCARD WHOSE BEVEL BENT WHEN TRYING TO INJECT ACUPAN INTO A SALINE BAG. IN ADDITION, WE SOMETIMES HAVE DIFFICULTY SAMPLING WITH CERTAIN TROCARDS OF THIS REFERENCE, WHATEVER THE PRODUCT. THE TROCARD WAS USED CORRECTLY. CLINICAL CONSEQUENCES AND CURRENT STATE OF THE PATIENT OR PERSON INVOLVED: NOTHING TO REPORT ACTIONS TAKEN FOR THE PATIENT WITH REGARD TO THE DM: CHANGE OF DEVICES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994345 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown