BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ

    MDR report key: 10657217 · Received October 9, 2020

    Report

    Report Number
    1911916-2020-00945
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 14, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0170296, MEDICAL DEVICE EXPIRATION DATE: 05/31/2025, DEVICE MANUFACTURE DATE: 06/18/2020, MEDICAL DEVICE LOT #: 0140472, MEDICAL DEVICE EXPIRATION DATE: 05/31/2025, DEVICE MANUFACTURE DATE: 05/19/2020. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBERS 0170296 & 0140472. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: NO SAMPLE WAS RECEIVED. NO PHOTO WAS PROVIDED. SAMPLE ANALYSIS COULD NOT BE PERFORMED, AND THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. ROOT CAUSE DESCRIPTION: WITH NO SAMPLE ANALYSIS IT IS NOT POSSIBLE TO OFFER A POTENTIAL ROOT CAUSE. RATIONALE: BASED ON INVESTIGATION CARRIED OUT AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING AND TRENDING THIS PRODUCT AND THIS SYMPTOM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD PISTON SYRINGES LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER HAD AN ISSUE WITH SYRINGE. ADDITIONAL INFORMATION [18-SEP-2020] VIA EMAIL: ARE YOU AWARE OF THE DATE(S) THAT THIS INCIDENT OCCURRED? THE DATE WAS (B)(6), THE SAME DATE THAT THE PSI WAS SUBMITTED. CAN YOU PROVIDE A FULL DESCRIPTION IF THE INCIDENT? I WAS DRAWING UP BLOOD PRODUCTS FROM THE 50 ML BD SYRINGE. FROM THE FIRST SYRINGE (PACKAGE DISCARDED PRIOR TO LOT # BEING COLLECTED, WAS NOT SAVED) I WAS DRAWING UP PLATELETS AND THE PRODUCT WAS LEAKING BEHIND THE PLUNGER, JUST ENOUGH TO CREATE MOISTURE BEHIND THE PLUNGER ON THE OUTSIDE OF THE SYRINGE. I DID NOT THINK MUCH OF IT AND ADMINISTERED THE BLOOD PRODUCT. WHEN I WAS DRAWING UP MY PRBC INFUSION, BLOOD WAS DRIPPING OUT FROM BEHIND THE PLUNGER. I USED ANOTHER SYRINGE (50 ML, BD) AND THE SAME THING HAPPENED. BOTH LOT NUMBERS WERE PROVIDED WITH THE ACUITY OF THE PATIENT, THE SYRINGES WERE ACCIDENTALLY DISCARDED. THE 3RD SYRINGE (FOR THE BLOOD PRODUCTS) DID NOT HAVE ANY LEAKAGE AND THE BLOOD PRODUCT WAS ADMINISTERED WITHOUT FURTHER DELAY. DID THIS INCIDENT OCCUR BEFORE, DURING OR AFTER USE? IF DURING USE: WAS THERE ANY PATIENT IMPACT OR DELAY IN TREATMENT? YES, SLIGHT DELAY IN ADMINISTRATION OF CRITICAL BLOOD PRODUCTS DUE TO SWITCHING BETWEEN SYRINGES. I WAS STILL ABLE TO ADMINISTER THE BLOOD PRODUCT WITHIN THE ALLOTTED TIME. WHAT WAS DONE TO COMPLETE THE TREATMENT? SWITCHING SYRINGES. ARE ANY PATIENT IDENTIFIERS AVAILABLE (I.E. INITIALS, GENDER, WEIGHT, ETC.)? MALE PATIENT WITH THE LAST NAME MOTE. I DO NOT HAVE ANY OTHER IDENTIFIERS. IS THE AFFECTED SAMPLE AVAILABLE TO BE RETURNED FOR INVESTIGATION? NO, THE SYRINGES WERE DISCARDED BY MISTAKE DUE TO THE ACUITY OF THE PATIENT, AND I DON¿T NOT HAVE A PHOTO. I WILL SAVE THE SYRINGE IF THIS OCCURS IN THE FUTURE. IF YES, IS THE SAMPLE LOCATED AT THE ADDRESS ABOVE? IF NO, CAN YOU PROVIDE A PHOTO OF THE DEFECT? EVENT DESCRIPTION PER ATTACHED EMAIL STATES: MY CUSTOMER REACHED OUT REGARDING AN ISSUE WITH THE 60ML SYRINGES. PLEASE REACH OUT REGARDING ISSUE OF DEFECTIVE SYRINGE. THE HERE ARE THE LOT NUMBER FOR THE PSN THAT WE HAVE LAST WEEK: . LOT #¿S 170296 AND 140472."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124001 SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other