BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT II 2 ML WITH 25G X 1

    MDR report key: 9476003 · Received December 16, 2019

    Report

    Report Number
    2243072-2019-02825
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    November 24, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. DATE RECEIVED BY MANUFACTURER: 2019-12-09 H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9190388 D.4. MEDICAL DEVICE EXPIRATION DATE: 6/30/2024 H.4. DEVICE MANUFACTURE DATE: 6/6/2019 H.6. INVESTIGATION SUMMARY: THE SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED SAMPLES OF (10) DISCARDIT 2ML 25GA FROM LOT # 9157828 AND 9190388 PRODUCT # 301866 WITH THE REPORTED ISSUES: DHR WAS REVIEWED FOR THE PRODUCT TEST. THE ENTIRE ROUTING TEST FOR REPORTED LOT FOUND WITHIN THE SPECIFICATION LIMIT. NO DISCREPANCY WAS REPORTED AND RECORDED IN DHR. THE CUSTOMER RETURN SAMPLES SHOWED THE EVIDENCE OF FOREIGN MATTER(HAIR) IN BLISTER PACK. THE TEAM INVESTIGATED THAT THIS IS A HUMAN ERROR AND HAS ACCIDENTLY FALLEN INTO THE CAVITY DURING PRODUCTION. ACTION PROPOSED TO PREVENT HAIR FROM FALLING INTO THE PRODUCT DURING PRODUCTION IS TO 1. RE-TRAIN MACHINE OPERATORS, 2. INCREASE GMP HYGIENE, 3. INCREASE USE OF GLOVES INSIDE CLEAN ROOM, 4. COVER MACHINES WITH PROTECTIVE GUARD IN OPEN SPACES 5. INCREASE MACHINE CLEANING FREQUENCY. THE CUSTOMER RETURN SAMPLES SHOWED THE EVIDENCE OF BLISTER DAMAGED DEFECT IN BLISTER PACK. THE TEAM VERIFIED THE CUSTOMER REPORTED SAMPLES AND DAMAGED BLISTER. THE TEAM INVESTIGATED THAT THE CUTTER CUTTING THE UNIT PACK IS WORKING ON A HIGH SPEED AND SOMETIMES IT RAPIDLY CUTS THE BLISTER ALONG WITH THE PRODUCT WHICH HAS ACCIDENTLY SHIFTED DUE TO MACHINE VIBRATIONS AND ACCELERATION. ACTION PROPOSED TO PREVENT DAMAGING BLISTERS IS TO CONTROL THE SPEED AND PRESSURE OF THE CUTTER. LONGITUDINAL CUTTER INDIVIDUALLY CONTROLLED BY SINGLE SEPARATE PRESSURE CONTROLLING MECHANISM. THE CUSTOMER RETURN SAMPLES SHOWED THE EVIDENCE OF BARREL PRINTING DEFECT IN BLISTER PACK. THE CUSTOMER RETURN SAMPLES SHOWED THE EVIDENCE OF ILLEGIBLE MARKING ON THE BARREL. THE TEAM VERIFIED THE CUSTOMER REPORTED SAMPLES AND FOUND MISSED MINOR MARKING ON THE BARREL. THE TEAM INVESTIGATED THE MARKING PROCESS AND ALL THE PROCESS PARAMETERS ARE WITHIN THE CONTROL LIMITS. THIS IS A STAMPING ISSUE. THE INK TRANSFERRING FROM STAMPING MACHINE TO THE BARREL IS MISSING SOME AREAS SOMETIMES. ACTION PROPOSED TO PREVENT MARKING DEFECT ON THE BARREL IS LOOK FOR BETTER QUALITY OF STAMPING FOIL THAT WILL ABSORB AND TRANSFER INK MARKING COMPLETELY. THE CUSTOMER RETURN SAMPLES SHOWED THE EVIDENCE OF BLACK SPOT (FOREIGN MATTER) PACKED IN BLISTER PACK. THE RAPID RESPONSE TEAM (RRT) INVESTIGATED AND FOUND FOLLOWING POTENTIAL CAUSE WHICH MAY LEAD TO ADDITION OF LOOSE FOREIGN PARTICLES PACKED IN BLISTER PACK. ¿ GENERATION OF BLACK PARTICLES DURING BARREL STAMPING. ¿ DRY INK GOT DRY IN VERTICAL PRINTING MACHINE AND MAY GET ADD IN BLISTER PACK. GENERATION DUE TO WIPER BRUSH ON SYRINGE AND NEEDLE LOADER. ACTION PROPOSED TO PREVENT BLACK FOREIGN MATTER(DRIED BLACK INK SPOT): 1). INCREASE THE CLEANING FREQUENCY FROM MONTHLY TO BI-WEEKLY OF DISCARDIT ASSEMBLY MACHINE. 2). CHANGE THE WIPER BRUSH ON MONTHLY BASIS. 3). REPLACE THE VERTICAL PRINTER TO HORIZONTAL PRINTING MACHINE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE DISCARDIT II 2 ML WITH 25G X 1 THERE WERE ISSUES WITH FOREIGN MATTER, MARKING DEFECTS, AND DAMAGE TO SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL HAS BEEN REJECTED WITH MANY REASONS THESE ARE THE DETAILS. 1) BLACK SPOT 2) FOREIGN PARTICLE 3) MARKING DEFECT 4) BLISTER DAMAGED 5) TWO NEEDLE IN ONE PACK 6) NO NEEDLE 7) DAMAGED SYRINGE 8) HAIR FOUND IN THE PACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE DISCARDIT II 2 ML WITH 25G X 1 THERE WERE ISSUES WITH FOREIGN MATTER, MARKING DEFECTS, AND DAMAGE TO SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL HAS BEEN REJECTED WITH MANY REASONS THESE ARE THE DETAILS. 1) BLACK SPOT 2) FOREIGN PARTICLE 3) MARKING DEFECT 4) BLISTER DAMAGED 5) TWO NEEDLE IN ONE PACK 6) NO NEEDLE 7) DAMAGED SYRINGE 8) HAIR FOUND IN THE PACK.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE DISCARDIT II 2 ML WITH 25G X 1 THERE WERE ISSUES WITH FOREIGN MATTER, MARKING DEFECTS, AND DAMAGE TO SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL HAS BEEN REJECTED WITH MANY REASONS THESE ARE THE DETAILS. BLACK SPOT, FOREIGN PARTICLE, MARKING DEFECT, BLISTER DAMAGED, TWO NEEDLE IN ONE PACK, NO NEEDLE, DAMAGED SYRINGE, HAIR FOUND IN THE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271894 DISCARDIT II 2 ML WITH 25G X 1 PISTON SYRINGE FMF BECTON DICKINSON 9190388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other