BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 12374145 · Received August 26, 2021

    Report

    Report Number
    3003916417-2021-00212
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 15, 2021
    Report Date
    August 31, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY LEAKAGE AT LUER CONNECTION: THROUGH THE ANALYSIS OF THE VIDEO SENT BY THE CUSTOMER, IT IS POSSIBLE TO OBSERVE THAT THE CLIENT PERFORMS A LEAK TEST WITH THE NEEDLE SHIELD STILL PRESENT IN THE HUB, WHICH CAUSES ALL THE LIQUID THAT PASSES THROUGH THE NEEDLE TO COME OUT OF THE SHIELD FITTING WITH THE HUB. THE CLIENT REPORTS THAT THE SYRINGE WAS CRACKED, AND NOT LEAKING IN THE CONNECTION. DUE TO THIS, BD DOES NOT CONFIRM THE CLAIM FOR THIS REASON. BARREL CRACKED: THROUGH THE ANALYSIS OF THE PHOTO AND VIDEO SENT BY THE CUSTOMER, IT IS NOT POSSIBLE TO OBSERVE THE BARREL CRACKED. THE CUSTOMER PERFORMS A LEAK TEST WITH THE NEEDLE SHIELD STILL PRESENT IN THE HUB, WHICH CAUSES ALL THE LIQUID THAT PASSES THROUGH THE NEEDLE TO COME OUT OF THE SHIELD'S FITTING WITH THE HUB. LEAKAGE IN THE SYRINGE BODY WAS NOT OBSERVED IN THE VIDEO. DUE TO THIS, BD DOES NOT CONFIRM THE CLAIM FOR THIS REASON. THE ANALYSIS OF THE BATCH HISTORY (DHR), MAINTENANCE RECORDS AND QUALITY NOTIFICATIONS WERE VERIFIED AND NO DEVIATION WAS FOUND FOR THIS BATCH. THE DEFECT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. AT THIS TIME, NO CORRECTIVE ACTIONS ARE NECESSARY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES FROM LOT 0133655 LEAKED, AND 1 SYRINGE FROM LOT 0133637 HAD A CRACKED BARREL AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "3ML SYRINGE IS DEFECTIVE, MEDICATION WAS WASTED. WHEN THEY PUT THE SOLUTION, IT LEAKS." "ON 15.JUL.2021, THE PHYSICIAN WAS DURING PROCEDURE WHEN WAS GOING TO INJECT COLORING AND ANESTHETIC (XYLESTESIN S/V AND METHYLENE BLUE), AND THE LIQUID THAT WAS INSIDE THE SYRINGE LEAKED. THE SYRINGE WAS CRACKED. THE SYRINGE WAS USED TO INJECT COLORING AND ANESTHETIC. PAAF PROCEDURE AND PRE-SURGERY MARKING. THERE WAS NO CONSEQUENCE TO PATIENT."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0133655, MEDICAL DEVICE EXPIRATION DATE: 2025-05-31, DEVICE MANUFACTURE DATE: 2020-05-28. MEDICAL DEVICE LOT #: 0133637, MEDICAL DEVICE EXPIRATION DATE: 2025-05-31, DEVICE MANUFACTURE DATE: 2020-05-28. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES FROM LOT 0133655 LEAKED, AND 1 SYRINGE FROM LOT 0133637 HAD A CRACKED BARREL AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "3ML SYRINGE IS DEFECTIVE, MEDICATION WAS WASTED. WHEN THEY PUT THE SOLUTION, IT LEAKS." "ON (B)(6) 2021, THE PHYSICIAN WAS DURING PROCEDURE WHEN WAS GOING TO INJECT COLORING AND ANESTHETIC (XYLESTESIN S/V AND METHYLENE BLUE), AND THE LIQUID THAT WAS INSIDE THE SYRINGE LEAKED. THE SYRINGE WAS CRACKED. THE SYRINGE WAS USED TO INJECT COLORING AND ANESTHETIC. PAAF PROCEDURE AND PRE-SURGERY MARKING. THERE WAS NO CONSEQUENCE TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270855 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1