BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 19238205 · Received May 3, 2024

    Report

    Report Number
    1911916-2024-00305
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 30, 2024
    Report Date
    June 5, 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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WERE SPLIT SEALS ON ONE SIDE. TO AID IN THE INVESTIGATION, THREE SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND ONE SIDE OF THE PACKAGING BLISTER IS NOT SEALED. THE PACKAGING BLISTER TOP WEB IS SHORTER BY 3.8". THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE PACKAGING BLISTER TOP WEB WAS MISALIGNED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 4059787. 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. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL# 302830 BATCH# 4059787 IT WAS REPORTED BY CUSTOMER THAT THEY FOUND SYRINGES BD302830 WITH SPLIT SEALS ON ONE SIDE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED CHC COMPLAINT REFERENCE #: PCS240501CM07T5 CUSTOMER (HOSPITAL) NAME: (B)(6) CUSTOMER ADDRESS: XXXX CONTACT NAME: XXXX PHONE: XXXX FAX: XXXX E-MAIL: (B)(6) CORRESPONDENCE LANGUAGE: ENGLISH CAT# OF PRODUCT BEING COMPLAINED: BD302830 DESCRIPTION OF PRODUCT: SYRINGE ONLY LUER-LOK 20CC TIP ST 48EA/BX 4BX/CA LOT OR S/N: (B)(6). COMPLAINT CATEGORY: DAMAGED / BROKEN RGA NUMBER: REPORTABLE: NO INCIDENT DATE: 30 APR 2024 HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): CUSTOMER FOUND SYRINGES BD302830 WITH SPLIT SEALS ON ONE SIDE, SEE ATTACHED PHOTO [**WILL BE SENT VIA SEPARATE EMAIL**]. BASED ON LOT # 4059787, AND AS PER JDE WE SHIPPED CUSTOMER TOTAL OF 5 BX ( 3 BX FROM 41108324 AND 2 BX FROM 41105303 ). CUSTOMER IS CHECKING THE REMAINING STOCK TO CONFIRM HOW MANY DEFECTIVE. SO FAR 19 FOUND. **CUSTOMER INDICATED THAT THEY WISH TO BE PROVIDED WITH THE FINAL RESULTS OF THIS INVESTIGATION. PLEASE COPY [email protected] WHEN SENDING TO THE CUSTOMER.** COMPLAINT NOTICED: PRIOR TO USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? UNKNOWN QTY AFFECTED: 1 BX SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: YES RETURN QTY: BEST REGARDS, CARDINAL HEALTH CANADA QUALITY ASSURANCE TEAM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL# 302830 BATCH# 4059787 IT WAS REPORTED BY CUSTOMER THAT THEY FOUND SYRINGES BD302830 WITH SPLIT SEALS ON ONE SIDE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED CHC COMPLAINT REFERENCE #: (B)(4). CUSTOMER (HOSPITAL) NAME: (B)(6). CORRESPONDENCE LANGUAGE: ENGLISH. CAT# OF PRODUCT BEING COMPLAINED: BD302830. DESCRIPTION OF PRODUCT: SYRINGE ONLY LUER-LOK 20CC TIP ST 48EA/BX 4BX/CA. LOT OR S/N: (B)(6). COMPLAINT CATEGORY: DAMAGED / BROKEN. RGA NUMBER: REPORTABLE: NO. INCIDENT DATE: 30 APR 2024. HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): CUSTOMER FOUND SYRINGES BD302830 WITH SPLIT SEALS ON ONE SIDE, SEE ATTACHED PHOTO [**WILL BE SENT VIA SEPARATE EMAIL**]. BASED ON LOT # 4059787, AND AS PER JDE WE SHIPPED CUSTOMER TOTAL OF 5 BX ( 3 BX FROM 41108324 AND 2 BX FROM 41105303 ). CUSTOMER IS CHECKING THE REMAINING STOCK TO CONFIRM HOW MANY DEFECTIVE. SO FAR 19 FOUND. **CUSTOMER INDICATED THAT THEY WISH TO BE PROVIDED WITH THE FINAL RESULTS OF THIS INVESTIGATION. PLEASE COPY [email protected] WHEN SENDING TO THE CUSTOMER.** COMPLAINT NOTICED: PRIOR TO USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: PATIENT INJURY: NO. HAS HEALTH CANADA BEEN INFORMED? UNKNOWN. QTY AFFECTED: 1 BX. SAMPLES AVAILABLE? NO. IS CUSTOMER REQUESTING AN RGA?: YES. RETURN QTY: BEST REGARDS, CARDINAL HEALTH CANADA QUALITY ASSURANCE TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278541 SYRINGE 20ML LL S/C 48 NEEDLE, HYPODERMIC, SINGLE LUMEN FMF BECTON DICKINSON 4059787 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown