BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 17546042 · Received August 14, 2023

    Report

    Report Number
    3003152976-2023-00326
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 28, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2211085, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO DAMAGE OR OTHER ISSUES WERE OBSERVED WITHIN THE PACKAGING, ALL SAMPLES COULD BE SEPARATED WITHOUT ISSUE. DURING THE PACKAGING PROCESS, ONCE THE PACKAGE IS SEALED, LONGITUDINAL CUTTERS CUT THE DIFFERENT BLISTERS, CREATING A DOTTED LINE FOR SEPARATION. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT WITHOUT ISSUE. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS POSSIBLE THIS INCIDENT OCCURRED DURING THE PACKAGING PROCESS AS A RESULT OF AN ISSUE WITH THE BLADES THAT CUT THE PACKAGING. GIVEN WE DO NOT HAVE A SAMPLE AND THE DEVICE RECORDS DID NOT IDENTIFY ANY ISSUES, THIS CANNOT BE CONFIRMED FOR THE INCIDENT REPORTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR UPDATED DEVICE EVALUATION AS PHYSICAL SAMPLE WAS RECEIVED: MULTIPLE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PROVIDED SAMPLES WERE RETURNED WITHOUT SEPARATION. OUR QUALITY TEAM SEPARATED THE UNITS WITHOUT ISSUE AND NO TEARING OF THE PACKAGE OCCURRED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2211085, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO DAMAGE OR OTHER ISSUES WERE OBSERVED WITHIN THE PACKAGING, ALL SAMPLES COULD BE SEPARATED WITHOUT ISSUE. DURING THE PACKAGING PROCESS, ONCE THE PACKAGE IS SEALED, LONGITUDINAL CUTTERS CUT THE DIFFERENT BLISTERS, CREATING A DOTTED LINE FOR SEPARATION. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT WITHOUT ISSUE. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS POSSIBLE THIS INCIDENT OCCURRED DURING THE PACKAGING PROCESS AS A RESULT OF AN ISSUE WITH THE BLADES THAT CUT THE PACKAGING. GIVEN WE DO NOT HAVE A SAMPLE AND THE DEVICE RECORDS DID NOT IDENTIFY ANY ISSUES, THIS CANNOT BE CONFIRMED FOR THE INCIDENT REPORTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    E. 1 INITIAL REPORTER PHONE #: (B)(6). B. 3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 PLASTIPAK¿ SYRINGE EXPERIENCED POOR PERFORATION PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: PLEASE FIND HERE SOME ADDITIONAL INFORMATION. PRODUCTS CONCERNED: SKU 300629 PLASTIPAK 20 ML LUER LOK ¿ LOT 2302075 SKU 305959 PLASTIPAK 10 ML LUER LOK ¿ LOT 2211085. COMPLAINT REASON: PERFORATION LINE BETWEEN BLISTER PACKS NOT COMPLETELY PUNCHED IN, DIFFICULT TO SEPARATE BLISTER PACKS FROM EACH OTHER WITHOUT TEARING THE PACKAGING. WE WILL ASK FOR SAMPLES. DEAR SIR OR MADAM, WE HAVE NOTICED FOR SOME WEEKS THAT THE PERFORATION ON THE PACKAGING IS NOT ALWAYS COMPLETE AND THAT WHEN THE BUNDLES ARE DIVIDED INTO THE INDIVIDUAL SYRINGES, THE PACKAGING TEARS AND THE SYRINGES ARE THEREFORE NO LONGER STERILE, WHICH WOULD BE ABSOLUTELY NECESSARY FOR OUR PURPOSES IN THE CLEAN ROOM. OUR CURRENT BATCH IS LOT 2302075 FOR 20 ML. THIS PROBLEM ALSO OCCURS WITH THE 10 ML SYRINGES (BATCH 10 ML LOT 2211085). ARE YOU AWARE OF THIS PROBLEM FROM OTHER CUSTOMERS? THANK YOU IN ADVANCE FOR YOUR FEEDBACK.

    Description of Event or Problem · 0

    PLEASE FIND HERE SOME ADDITIONAL INFORMATION. PRODUCTS CONCERNED: SKU 300629 PLASTIPAK 20 ML LUER LOK ¿ LOT 2302075 SKU 305959 PLASTIPAK 10 ML LUER LOK ¿ LOT 2211085 COMPLAINT REASON: PERFORATION LINE BETWEEN BLISTER PACKS NOT COMPLETELY PUNCHED IN, DIFFICULT TO SEPARATE BLISTER PACKS FROM EACH OTHER WITHOUT TEARING THE PACKAGING. WE WILL ASK FOR SAMPLES. DEAR SIR OR MADAM, WE HAVE NOTICED FOR SOME WEEKS THAT THE PERFORATION ON THE PACKAGING IS NOT ALWAYS COMPLETE AND THAT WHEN THE BUNDLES ARE DIVIDED INTO THE INDIVIDUAL SYRINGES, THE PACKAGING TEARS AND THE SYRINGES ARE THEREFORE NO LONGER STERILE, WHICH WOULD BE ABSOLUTELY NECESSARY FOR OUR PURPOSES IN THE CLEAN ROOM. OUR CURRENT BATCH IS LOT 2302075 FOR 20 ML. THIS PROBLEM ALSO OCCURS WITH THE 10 ML SYRINGES (BATCH 10 ML LOT 2211085). ARE YOU AWARE OF THIS PROBLEM FROM OTHER CUSTOMERS? THANK YOU IN ADVANCE FOR YOUR FEEDBACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE EXPERIENCED POOR PERFORATION PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: PLEASE FIND HERE SOME ADDITIONAL INFORMATION. PRODUCTS CONCERNED: SKU 300629 PLASTIPAK 20 ML LUER LOK ¿ LOT 2302075. SKU 305959 PLASTIPAK 10 ML LUER LOK ¿ LOT 2211085. COMPLAINT REASON: PERFORATION LINE BETWEEN BLISTER PACKS NOT COMPLETELY PUNCHED IN, DIFFICULT TO SEPARATE BLISTER PACKS FROM EACH OTHER WITHOUT TEARING THE PACKAGING. WE WILL ASK FOR SAMPLES. DEAR SIR OR MADAM, WE HAVE NOTICED FOR SOME WEEKS THAT THE PERFORATION ON THE PACKAGING IS NOT ALWAYS COMPLETE AND THAT WHEN THE BUNDLES ARE DIVIDED INTO THE INDIVIDUAL SYRINGES, THE PACKAGING TEARS AND THE SYRINGES ARE THEREFORE NO LONGER STERILE, WHICH WOULD BE ABSOLUTELY NECESSARY FOR OUR PURPOSES IN THE CLEAN ROOM. OUR CURRENT BATCH IS LOT 2302075 FOR 20 ML. THIS PROBLEM ALSO OCCURS WITH THE 10 ML SYRINGES (BATCH 10 ML LOT 2211085). ARE YOU AWARE OF THIS PROBLEM FROM OTHER CUSTOMERS? THANK YOU IN ADVANCE FOR YOUR FEEDBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52280 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown