BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD STERILE SYRINGE CONVENIENCE TRAYS

    MDR report key: 17439211 · Received August 1, 2023

    Report

    Report Number
    1920898-2023-00496
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 12, 2023
    Report Date
    October 30, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE PAST STOPPER WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTO. ONE PHOTO WAS EXAMINED FOR THE COMPLAINT DEFECT. THERE IS AN OBSERVED CLEAR LIQUID BEHIND THE STOPPER NEAR THE PLUNGER. THIS LIQUID APPEARS TO BE MUCH CLEARER THAN THE DRAWN SUBSTANCE. THIS COULD BE EXCESS SILICONE FROM THE STOPPER. HOWEVER, WE ARE UNABLE TO DETERMINE THE IDENTITY OF THE LIQUID WITHOUT A SAMPLE. LEAKAGE IN A SYRINGE CAN OCCUR DUE TO A ROLLED STOPPER OR EXCESS CLEARANCE BETWEEN THE STOPPER AND THE SYRINGE. NEITHER CAUSE IS OBSERVED IN THE PHOTO PROVIDED AND CANNOT BE CONFIRMED WITHOUT A SAMPLE FOR FURTHER INVESTIGATION. BD CANNOT CONFIRM THE CAUSE OF THE FAILURES TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED FAILURE. THERE ARE CURRENTLY SYSTEMS IN PLACE TO PREVENT THE OCCURRENCE OF THE REPORTED DEFECT DURING MANUFACTURING. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MAT# 309703 ; BATCH# 3033059. IT WAS REPORTED BY THE CUSTOMER THAT THEY PRE-FILL SYRINGES WITH DRUG SOLUTION FOR NURSING STAFF TO ADMINISTER FOR PATIENTS AND THEY HAVE NOTICED THAT THE SYRINGES ARE LEAKING. SYRINGES LEAKING IN PHARMACY ARE CAUGHT AND DISPOSED OF BUT IF ANYTHING LEAKS AFTER IT HAS BEEN DISPENSED TO NURSING STAFF IT IS POSSIBLE THAT THE STERILITY OF THE SYRINGE IS CONTAMINATED, AND THE PATIENT WILL NOT GET THEIR FULL DOSE. OCCURRENCES: 4 EACH. COMPLAINT RECEIVED VIA EMAIL. PRODUCT PROBLEM REPORT: PRODUCT INFORMATION: PRODUCT CODE: 309703. PRODUCT DESCRIPTION: SYRINGE HYPO 5CC L/L STERILE CON- LOT/SERIAL #:(B)(6). EXPIRY DATE: 2027-09-30. PROBLEM INFORMATION USE CUSTOMER REF# (B)(4). WE PRE-FILL SYRINGES WITH DRUG SOLUTION FOR NURSING STAFF TO ADMINISTER FOR PATIENTS AND WE HAVE NOTICED THAT THE SYRINGES ARE LEAKING. SYRINGES LEAKING IN PHARMACY ARE CAUGHT AND DISPOSED OF BUT IF ANYTHING LEAKS AFTER IT HAS BEEN DISPENSED TO NURSING STAFF IT¿S POSSIBLE THAT THE STERILITY OF THE SYRINGE IS CONTAMINATED AND THE PATIENT WILL NOT GET THEIR FULL DOSE. OCCURRENCES: 4 EACH. REPORTER INFORMATION REPORTER POSITION/DEPARTMENT: PHARMACY. REPORTER PHONE: (B)(6). REPORTER EMAIL: (B)(6). SITE INFORMATION: (B)(6). SAMPLE INFORMATION INCIDENT SAMPLES: 0. REPRESENTATIVE SAMPLES: 0. NO ADVERSE EVENT REPORTED. 1ST CUSTOMER RESPONSE: ARE YOU ABLE TO PROVIDE THE INCIDENT DATES CORRESPONDING TO THE NUMBER OF OCCURRENCES? NUMBER OF OCCURENCES: INCIDENT DATES: 1; (B)(6) 2023. 2; (B)(6) 2023. 3; (B)(6) 2023. 4; (B)(6) 2023. IF YOU ARE UNABLE TO SEND A SAMPLE, COULD YOU PROVIDE ANY PHOTO/VIDEO OF THE REPORTED ISSUE? YES, PHOTO IS ATTACHED. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? EXTRA WORKLOAD DUE TO REPLACING THE SYRINGES. WHAT TYPE OF PROCEDURE IS BEING PERFORMED? PRE-FILLING DRUG SOLUTION INTO SYRINGES FOR NURSING TO DISPENSE/ADMINISTER TO PATIENTS. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? DIACETYLMORPHINE AND HYDROMORPHONE. WHERE SPECIFICALLY WAS THE LEAKAGE? FROM THE BOTTOM OF SEAL/STOPPER OF THE SYRINGE WHERE THE PLUNGER IS LOCATED . WERE THERE ANY NOTICEABLE DEFECTS ON THE LUER / STOPPER / CONNECTION / NEEDLE? NO. IF PAST THE STOPPER, WAS IT ALL THE WAY PAST THE STOPPER OR ONLY WITHIN THE RIBS OF THE STOPPER? SOME WITHIN THE STOPPER AND SOME PAST THE STOPPER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD STERILE SYRINGE CONVENIENCE TRAYS LEAKAGE OCCURRED 4 TIMES. THIS IS REPORT 2 OF 4. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT/SERIAL #: (B)(6). EXPIRY DATE: 2027-09-30. PROBLEM INFORMATION **USE CUSTOMER REF# (B)(4)** WE PRE-FILL SYRINGES WITH DRUG SOLUTION FOR NURSING STAFF TO ADMINISTER FOR PATIENTS AND WE HAVE NOTICED THAT THE SYRINGES ARE LEAKING. SYRINGES LEAKING IN PHARMACY ARE CAUGHT AND DISPOSED OF BUT IF ANYTHING LEAKS AFTER IT HAS BEEN DISPENSED TO NURSING STAFF IT¿S POSSIBLE THAT THE STERILITY OF THE SYRINGE IS CONTAMINATED AND THE PATIENT WILL NOT GET THEIR FULL DOSE. OCCURRENCES: 4 EACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457931 BD STERILE SYRINGE CONVENIENCE TRAYS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 3033059 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown