BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18416952 · Received December 29, 2023

    Report

    Report Number
    1920898-2023-00854
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    December 15, 2023
    Report Date
    July 2, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE IT IS POSSIBLE THE FM/"CLEAR LIQUID" OBSERVED IN THE SYRINGE IS SILICONE. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF (B)(4) UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. PLEASE SEE SILICONE QUANTITY GUIDELINE ATTACHED. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT IS GOING TO BD. CONSUMER REPORTED SEEING FOREIGN MATTER IN BARREL OF SYRINGES. HE DESCRIBED IT AS A "CLEAR LIQUID." STATED, HE DID NOT USE SYRINGES HE FOUND WITH THE "CLEAR LIQUID". STATED, WHEN "CLEAR LIQUID" IS EXPOSED TO "AIR" IT TURNS "HARD/SOLID" GIVING THE APPEARANCE OF CLEAR NAIL POLISH. LOT: 3251132. CATALOG: 309628. HE STATED, HE NOTICED THE ISSUE LAST WEEK BUT COULD NOT PROVIDE AN EXACT "DATE OF EVENT" SAMPLES: YES. CONSUMER IS USING THE BD PRODUCT FOR TESTOSTERONE INJECTION STATED, HE IS A CANCER PATIENT SO HE NEEDS TO BE CAREFUL ON WHAT GOES INTO HIS BODY. (B)(6).

    Description of Event or Problem · 0

    MATERIAL#: 309628 BATCH NUMBER#: 3251132. IT WAS REPORTED BY CONSUMER THAT CONSUMER REPORTED SEEING FOREIGN MATTER IN BARREL OF SYRINGES. HE DESCRIBED IT AS A "CLEAR LIQUID" . STATED, HE DID NOT USE SYRINGES HE FOUND WITH THE "CLEAR LIQUID". STATED, WHEN "CLEAR LIQUID" IS EXPOSED TO "AIR" IT TURNS "HARD/SOLID" GIVING THE APPEARANCE OF CLEAR NAIL POLISH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT IS GOING TO BD CONSUMER REPORTED SEEING FOREIGN MATTER IN BARREL OF SYRINGES. HE DESCRIBED IT AS A "CLEAR LIQUID" STATED, HE DID NOT USE SYRINGES HE FOUND WITH THE "CLEAR LIQUID". STATED, WHEN "CLEAR LIQUID" IS EXPOSED TO "AIR" IT TURNS "HARD/SOLID" GIVING THE APPEARANCE OF CLEAR NAIL POLISH. LOT: 3251132 CATALOG: 309628 HE STATED, HE NOTICED THE ISSUE LAST WEEK BUT COULD NOT PROVIDE AN EXACT "DATE OF EVENT" SAMPLES: YES CONSUMER IS USING THE BD PRODUCT FOR TESTOSTERONE INJECTION STATED, HE IS A CANCER PATIENT SO HE NEEDS TO BE CAREFUL ON WHAT GOES INTO HIS BODY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245357 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 3251132 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown