BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 18838015 · Received March 5, 2024

    Report

    Report Number
    1911916-2024-00161
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 19, 2024
    Report Date
    March 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    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

    (B)(4), FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS DIRT INSIDE THE PLASTIC WRAP. TO AID IN THE INVESTIGATION, SEVENTY-TWO SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. SEVENTY-ONE SAMPLES CAME IN SEALED PACKAGING BLISTERS AND ONE SAMPLE CAME IN AN OPENED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED. SIXTEEN SAMPLE HAVE A DARK COLORED PARTICLE, 1/32" IN SIZE, ADHERED TO THE PACKAGING BLISTER BOTTOM WEB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF CLEANING OF THE PACKAGING PROCESS WAS NOT EFFECTIVELY COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 3235904. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE PACKAGING PROCESS WAS PERFORMED, AND NO FOREIGN MATTER OF ANY KIND WAS OBSERVED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    PR (B)(6): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. MATERIAL #:302830, BATCH#:3235904. IT WAS REPORTED BY CUSTOMER THAT THE SYRINGES HAS DIRT INSIDE THE PLASTIC WRAP. VERBATIM: HELLO, WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. STEVENS REF#PC-240215 HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION: PRODUCT PROBLEM REPORT, PRODUCT INFORMATION. PRODUCT CODE: 302830. PRODUCT DESCRIPTION: SYRINGE, 20ML LEUR LOCK. LOT/SERIAL #:(B)(6). EXPIRY DATE: 2028-08-31. PROBLEM INFORMATION: SYRINGES HAS DIRT INSIDE THE PLASTIC WRAP. OCCURRENCES: 1 EACH. REPORTER INFORMATION: REPORTER NAME: (B)(6). REPORTER POSITION/DEPARTMENT: CLINICAL VALUE ANALYSIS SPECIALIST CVAS- ACUTE CARE & ALL SURGICAL SPECIALTIES-OR/MDR REPORTER PHONE: (B)(6) REPORTER EMAIL: (B)(6) SITE INFORMATION: (B)(6). SAMPLE INFORMATION: INCIDENT SAMPLES: PENDING. REPRESENTATIVE SAMPLES: 0. POTENTIAL ADVERSE EVENT: DESCRIPTION OF ADVERSE EVENT: HARM. DATE OF EVENT: ADDITIONAL INFORMATION: PLEASE PROVIDE THE DATE OF EVENT. FEB 19TH ¿ THE FIRST BLACK MARKS/SUBSTANCE WAS SPOTTED WITHIN THE SYRINGE PACKAGING ¿ ALL SYRINGES FROM OPEN CASES OF THE SAME LOT WERE REVIEWED, AND SEQUESTERED. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? NOT AS FAR AS WE CAPTURED, BUT WE¿RE UNABLE TO CONFIRM IF MORE OF THIS LOT HAD BEEN USED PRIOR TO THE DATE ABOVE (WITHOUT CONTAMINATION SPOTTED). DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PLEASE INCLUDE TREATMENT/INTERVENTION PROVIDED AND THE OUTCOME. NO PLEASE CONFIRM THE NUMBER OF OCCURRENCES. N/A (14 SYRINGES HAVE VISIBLE SUBSTANCE).

    Description of Event or Problem · 0

    MATERIAL #:302830 BATCH#:3235904. IT WAS REPORTED BY CUSTOMER THAT THE SYRINGES HAS DIRT INSIDE THE PLASTIC WRAP. VERBATIM: HELLO, WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. STEVENS REF# (B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION: PRODUCT PROBLEM REPORT PRODUCT INFORMATION PRODUCT CODE: 302830 PRODUCT DESCRIPTION: SYRINGE, 20ML LEUR LOCK LOT/SERIAL #: (B)(6) EXPIRY DATE: 2028-08-31 PROBLEM INFORMATION SYRINGES HAS DIRT INSIDE THE PLASTIC WRAP. OCCURRENCES: 1 EACH. REPORTER INFORMATION REPORTER NAME: (B)(6) REPORTER POSITION/DEPARTMENT: CLINICAL VALUE ANALYSIS SPECIALIST CVAS- ACUTE CARE & ALL SURGICAL SPECIALTIES-OR/MDR REPORTER PHONE: (B)(6) REPORTER EMAIL: (B)(6) SITE INFORMATION (B)(6). SAMPLE INFORMATION INCIDENT SAMPLES: PENDING REPRESENTATIVE SAMPLES: 0. POTENTIAL ADVERSE EVENT DESCRIPTION OF ADVERSE EVENT: HARM DATE OF EVENT:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139082 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 3235904 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown