BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ CATHETER TIP SYRINGE

    MDR report key: 17477058 · Received August 7, 2023

    Report

    Report Number
    1911916-2023-00557
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 14, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30AUG2023. H6: INVESTIGATION SUMMARY: IT WAS REPORTED A UNIT WAS RECEIVED WITH A MANUFACTURING DEFECT. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A SEALED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE IS A LOOSE PIECE OF PLASTIC AT THE TOP OF THE SYRINGE; IT IS A PIECE OF PLUNGER ROD RIB. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303553, LOT 2179838. 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 SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ CATHETER TIP SYRINGE WAS DAMAGED IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "WE RECEIVED A TECHNICAL COMPLAINT REGARDING THE MATERIAL DISPOSABLE SYRINGE 50ML LONG CATHETER NOZZLE REF 303553, WHICH PRESENTS A MANUFACTURING DEFECT. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION. ¿ REGARDING THE APPEARANCE OF THE DEVIATION, IS THERE ANY DIRT? NO. ¿ CHARACTERISTICS/APPEARANCE OF FOREIGN MATTER (EG RUST, GREASE, PAPER, INSECT, ETC.); NO. ¿ IS FOREIGN MATTER EMBEDDED IN THE MATERIAL? NO. ¿ IS THE FOREIGN MATTER IN THE PACKAGING, IS IT IN THE PLASTIC WRAP OR ON THE PAPER? NO. ¿ DOES THE PRODUCT HAVE ANY PROTRUSION? EX.: IS IT DAMAGED, CROOKED, WITH A LEAK, PUNCTURED? YES. ¿ WAS THE PACKAGE TORN AND/OR VIOLATED? NO."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ CATHETER TIP SYRINGE WAS DAMAGED IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "WE RECEIVED A TECHNICAL COMPLAINT REGARDING THE MATERIAL DISPOSABLE SYRINGE 50ML LONG CATHETER NOZZLE REF (B)(4), WHICH PRESENTS A MANUFACTURING DEFECT... CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION. REGARDING THE APPEARANCE OF THE DEVIATION, IS THERE ANY DIRT? NO. CHARACTERISTICS/APPEARANCE OF FOREIGN MATTER (EG RUST, GREASE, PAPER, INSECT, ETC.); NO. IS FOREIGN MATTER EMBEDDED IN THE MATERIAL? NO. IS THE FOREIGN MATTER IN THE PACKAGING, IS IT IN THE PLASTIC WRAP OR ON THE PAPER? NO. DOES THE PRODUCT HAVE ANY PROTRUSION? EX.: IS IT DAMAGED, CROOKED, WITH A LEAK, PUNCTURED? YES. WAS THE PACKAGE TORN AND/OR VIOLATED? NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458468 BD¿ CATHETER TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2179838

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown