BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL TIP CONV PAK

    MDR report key: 9385762 · Received November 27, 2019

    Report

    Report Number
    9610847-2019-00705
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 11, 2019
    Report Date
    February 20, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903056171
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 8198794 AND ALL RELATED SUB-ASSEMBLY PRODUCT LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, OUR QUALITY ENGINEER TEAM WAS UNABLE TO COMPLETE A THOROUGH SAMPLE INVESTIGATION. AT THIS TIME, A CAUSE FOR THE REPORTED INCIDENT CAN NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A SYRINGE 20ML LL TIP CONV PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I AM THE STERILE PRODUCTS SUPERVISOR. WE USE BD SYRINGES IN OUR IV PRODUCTION PROCESSES. RECENTLY, WE HAVE HAD NUMEROUS INSTANCES OF DRUG FLUID LEAKING FROM THE SYRINGE INTO THE SPACE BETWEEN THE FIRST AND SECOND RIBS OF THE PLUNGER. WE DID SOME RESEARCH AND FOUND THE FOLLOWING ISMP ARTICLE REGARDING A SIMILAR ISSUE IN 2016. THE ARTICLE STATES: "IN ASSESSMENTS BD HAS MADE, THE COMPANY FOUND THAT LEAKAGE INTO THE AREA BETWEEN THE FIRST AND SECOND RIBS OF THE STOPPER RETAINS THE STERILITY OF THE FLUID AND IN MOST INSTANCES HAS NO IMPACT ON THE VOLUMETRIC ACCURACY OF THE DELIVERY OF THE MEDICATION." WHAT ASSESSMENTS WERE MADE TO DETERMINE THE STERILITY OF THE MEDICATION? HOW DO YOU GUARANTEE THE STERILITY OF THE PRODUCT DURING STORAGE AT THE PATIENT BEDSIDE? WE ARE SEEING THIS WITH 10 ML, 20 ML AND 60 ML SYRINGES. THE AFFECTED LOTS ARE: 9113693 (10 ML), 8198794 (20 ML), 9211314 (60 ML) AND 9242233 (60 ML). PLEASE RESPOND ASAP AS THIS IS AN URGENT MATTER. IF WE CANNOT GUARANTEE THE STERILITY OF THE SYRINGES AND THEIR PRODUCTS, WE WILL BE UNABLE TO PROVIDE PATIENT CARE. DURING CALL ON 11/12, CUSTOMER STATED THAT THE MEDICATION HAS NOT COMPLETELY LEAKED PAST THE STOPPER TO CAUSE EXPOSURE AND IS NOT SPECIFIC TO ONE MEDICATION. ISSUES STARTED TO BE REPORTED ON FRIDAY, 11/08, AND WAS AN ONGOING ISSUE OVER THE WEEKEND. NO SPECIFIC DATES OF OCCURRENCE OR PATIENT IDENTIFIERS ARE AVAILABLE." 1 OF 3 COMPLAINTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A SYRINGE 20ML LL TIP CONV PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I AM THE STERILE PRODUCTS SUPERVISOR. WE USE BD SYRINGES IN OUR IV PRODUCTION PROCESSES. RECENTLY, WE HAVE HAD NUMEROUS INSTANCES OF DRUG FLUID LEAKING FROM THE SYRINGE INTO THE SPACE BETWEEN THE FIRST AND SECOND RIBS OF THE PLUNGER. WE DID SOME RESEARCH AND FOUND THE FOLLOWING ISMP ARTICLE REGARDING A SIMILAR ISSUE IN 2016. THE ARTICLE STATES: "IN ASSESSMENTS BD HAS MADE, THE COMPANY FOUND THAT LEAKAGE INTO THE AREA BETWEEN THE FIRST AND SECOND RIBS OF THE STOPPER RETAINS THE STERILITY OF THE FLUID AND IN MOST INSTANCES HAS NO IMPACT ON THE VOLUMETRIC ACCURACY OF THE DELIVERY OF THE MEDICATION." WHAT ASSESSMENTS WERE MADE TO DETERMINE THE STERILITY OF THE MEDICATION? HOW DO YOU GUARANTEE THE STERILITY OF THE PRODUCT DURING STORAGE AT THE PATIENT BEDSIDE? WE ARE SEEING THIS WITH 10 ML, 20 ML AND 60 ML SYRINGES. THE AFFECTED LOTS ARE: 9113693 (10 ML), 8198794 (20 ML), 9211314 (60 ML) AND 9242233 (60 ML). PLEASE RESPOND ASAP AS THIS IS AN URGENT MATTER. IF WE CANNOT GUARANTEE THE STERILITY OF THE SYRINGES AND THEIR PRODUCTS, WE WILL BE UNABLE TO PROVIDE PATIENT CARE. DURING CALL ON 11/12, CUSTOMER STATED THAT THE MEDICATION HAS NOT COMPLETELY LEAKED PAST THE STOPPER TO CAUSE EXPOSURE AND IS NOT SPECIFIC TO ONE MEDICATION. ISSUES STARTED TO BE REPORTED ON FRIDAY, 11/08, AND WAS AN ONGOING ISSUE OVER THE WEEKEND. NO SPECIFIC DATES OF OCCURRENCE OR PATIENT IDENTIFIERS ARE AVAILABLE." 1 OF 3 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182350 SYRINGE 20ML LL TIP CONV PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 305617 8198794 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other