BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE

    MDR report key: 7530331 · Received May 21, 2018

    Report

    Report Number
    2243072-2018-00289
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    April 30, 2018
    Report Date
    August 23, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 2 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER 1803194. SBDM NOTICED EXCESS SILICONE LUBRICANT ON THE STOPPER. TESTING: WITH THE 2 SAMPLES, SBDM CONDUCTED SILICONE LUBRICANT TEST ACCORDING TO ARTICLE NO. 9, MEDICAL DEVICE REGULATORY STANDARD, TESTING METHOD OF SILICONE LUBRICANT. SILICON IN THE MEDICAL DEVICE STANDARD: BELOW 0.25 MG/¿ FOR RESULTS, SAMPLE 1 CONTAIN 0.2445 MG/¿, WHILE SAMPLE 2 CONTAIN 0.2140 MG/¿. BOTH RETURNED SAMPLES MET THE REGULATORY STANDARD ON MEDICAL DEVICE MANUFACTURING. HOUSE SAMPLE INSPECTION - SBDM INSPECTED 30 PCS FROM LOT 1803194, THERE ARE NO ISSUES OBSERVED. DHR REVIEW - SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1803194, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED CUSTOMER COMPLAINT FOR LOT 1803194, THERE ARE NO REPEATED SAME ISSUE FROM OTHER CUSTOMERS. INVESTIGATION CONCLUSION: FROM INVESTIGATIONS, BOTH RETURNED SAMPLES MET SILICONE LUBRICANT TEST ACCORDING TO ARTICLE NO. 9, MEDICAL DEVICE REGULATORY STANDARD. THE LIKELY CAUSE IS THE STOPPER PUSHED SILICONE LUBRICANT INSIDE OF THE BARREL AND THE SILICON LUBRICANT MASS SEEMS ON THE BOTTOM OF BARREL. THAT MAY MAKE THE CUSTOMER THOUGHT SILICONE VOLUME IS EXCESSIVE. FURTHERMORE, IN SBDM 20ML SYRINGE MANUFACTURING PROCESS, THEY ARE CONTROLLING INTERNAL STANDARD ON THE SILICONE LUBRICANT VOLUME AS BELOW 0.2000MG, THAT IS MORE TIGHTENED CONTROL POINT THAN THE CURRENT MEDICAL DEVICE REGULATORY GUIDELINE. CORRECTIVE ACTIONS: 1. SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS.1. 2. SBDM RECHECKED THE SILICONE SPRAY UNIT FOR SYRINGE ASSEMBLY PROCESS AND ALSO IMPLEMENTED PREVENTIVE MAINTENANCE FOR THE SILICONE SPRAY UNIT. WE WILL CONTROL INTERNAL GUIDELINE FOR SILICONE LUBRICANT STANDARD AS BELOW 0.2000MG. 3. SBDM STRENGTHEN PROCESS MONITORING & PRODUCT INSPECTION DURING SYRINGE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE A BD¿ SYRINGE WAS FOUND WITH FOREIGN MATTER AS " THE STOPPER HAS TOO MUCH LUBRICANT." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE A BD¿ SYRINGE WAS FOUND WITH FOREIGN MATTER AS " THE STOPPER HAS TOO MUCH LUBRICANT." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA, THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD¿ SYRINGE WAS FOUND WITH FOREIGN MATTER AS "THE STOPPER HAS TOO MUCH LUBRICANT". THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371809 BD¿ SYRINGE SYRINGE FMF BECTON DICKINSON 1803194

    Patients

    Seq Age Sex Outcome Treatment
    1 Other