BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED¿ SYRINGE

    MDR report key: 7452716 · Received April 23, 2018

    Report

    Report Number
    3003916417-2018-00057
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    February 9, 2018
    Report Date
    May 11, 2018
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7054746. MEDICAL DEVICE EXPIRATION DATE: 2/28/2022. DEVICE MANUFACTURE DATE: 3/6/2017. MEDICAL DEVICE LOT #: 7072696. MEDICAL DEVICE EXPIRATION DATE: 3/31/2022. DEVICE MANUFACTURE DATE: 4/4/2017. INVESTIGATION SUMMARY: SAMPLES/ PHOTOS ANALYSIS: THE IMAGE AND SAMPLE SENT BY THE CUSTOMER WERE VERIFIED AND IT WAS POSSIBLE TO OBSERVE BARREL DAMAGE. DHR REVIEW: THE BATCH RECORD WAS VERIFIED AND THE MANUFACTURING DATE FOR THE BATCH WAS 7054746: MARCH 02ND AND 04TH, 2017 AND BATCH 7072696: WAS APRIL 10TH AND 12TH, 2017. THE PROCESS INSPECTIONS WERE PERFORMED AT PROPER FREQUENCY AND NO RECORDS OF THIS DEFECT WERE FOUND. THE CURRENT CONTROLS AT MANUFACTURING PROCESS TO DETECT THE DEFECT ARE PERFORMED BY VISUAL INSPECTION EVERY 2 HOURS AT 36 PARTS AT ASSEMBLY MACHINE; QN REVIEW: NO QUALITY NOTIFICATION (QN) THAT COULD RELATED TO DEFECT WERE OBSERVED. MAINTENANCE REVIEW: NO MAINTENANCE RECORD THAT COULD RELATED TO DEFECT WERE OBSERVED. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO CONFIRM/ REPRODUCE THE INCIDENT IN QUESTION. DHR, QUALITY NOTIFICATION, AND MAINTENANCE ANALYSIS WERE PERFORMED AND NO OCCURRENCES POTENTIALLY RELATED TO THE DEFECT WAS OBSERVED. THE IMAGE AND SAMPLE SENT BY THE CUSTOMER WERE VERIFIED AND IT WAS POSSIBLE OBSERVE BARREL CRACKED. THE POTENTIAL CAUSE FOR THE PROBLEM IS A BARREL JAM ON ASSEMBLY MACHINE SYSTEM. THAT JAM IS INHERENT TO THE MANUFACTURING PROCESS AND OCCURS OCCASIONALLY ON THE PROCESS. AS INTERNAL ACTION FOR PRODUCT QUALITY IMPROVEMENT, WILL BE PERFORMED THE BLITZ # 44/2018 FOR DEFECTS OF DAMAGED COMPONENTS AND LEAKAGE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 BY "MS. (B)(6), A NURSE, WENT TO DRAW UP DIPROSPAN INTO THE BD SOLOMED¿ SYRINGE, THE UNIT FILLED MORE AIR THAN THE ACTUAL MEDICINE. SHE REPORTED THAT WHEN SHE WENT TO USE THE PRODUCT ON THE PATIENT, THE PRODUCT WOULD NOT PIERCE THE PATIENTS SKIN MAKING THE PRODUCT UNUSABLE. THE PATIENT NEEDED TO BUY A NEW PRODUCT FROM ANOTHER MANUFACTURER. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292969 BD SOLOMED¿ SYRINGE SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other