BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK

    MDR report key: 25156284 · Received May 12, 2026

    Report

    Report Number
    3003152976-2026-00228
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. G.4. APPLICABLE 510K NUMBERS ARE K182589;K980987. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 50ML LL HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE POTENTIAL QUALITY DEFECT IDENTIFIED IN A BATCH OF BD 50 ML SYRINGES CURRENTLY IN OUR POSSESSION/USE. DURING ROUTINE INSPECTION/USE, WE IDENTIFIED AN OILY RESIDUE PRESENT WITHIN THE SYRINGE BARREL AND ON THE PLUNGER BUNG OF MULTIPLE UNITS FROM THE SAME BATCH. THE RESIDUE APPEARS VISIBLE UPON EXAMINATION AND RAISES CONCERNS REGARDING PRODUCT QUALITY, SUITABILITY FOR USE, AND POTENTIAL PATIENT SAFETY IMPLICATIONS. SEE ATTACHED PHOTOGRAPHS. THE AFFECTED PRODUCT DETAILS ARE AS FOLLOWS: PRODUCT: BD 50 ML SYRINGES. BATCH/LOT NUMBER: 2511043. BATCH EXP: 31/10/30. QUANTITY AFFECTED: 1 BOX 50 . AT THIS STAGE, THE AFFECTED STOCK HAS BEEN QUARANTINED PENDING FURTHER INVESTIGATION. WE REQUEST THAT BD URGENTLY INVESTIGATE THIS MATTER AND ADVISE ON: WHETHER SIMILAR COMPLAINTS OR NON-CONFORMANCES HAVE BEEN REPORTED PREVIOUSLY. THE POTENTIAL SOURCE AND COMPOSITION OF THE OILY RESIDUE. ANY ASSOCIATED PATIENT SAFETY OR PRODUCT PERFORMANCE RISKS. RECOMMENDED ACTIONS REGARDING QUARANTINE, RETURN, REPLACEMENT, SAFETY MEASURES. PLEASE ALSO ADVISE WHETHER SAMPLES SHOULD BE RETAINED OR RETURNED FOR LABORATORY ANALYSIS, AND PROVIDE DETAILS OF THE APPROPRIATE COMPLAINT HANDLING PROCESS AND REFERENCE NUMBER FOR THIS CASE. WE WOULD APPRECIATE ACKNOWLEDGMENT OF THIS NOTIFICATION AND A PROMPT RESPONSE GIVEN THE POTENTIAL IMPACT ON CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428192 BD PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2511043 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown