BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT II 2 ML WITH 25G X 1

    MDR report key: 12215650 · Received July 22, 2021

    Report

    Report Number
    2243072-2021-01957
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 28, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-07-26 H6: INVESTIGATION SUMMARY THE SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED SAMPLES (16) DISCARDIT 2ML, FROM LOT # 0214097, ITEM # 301866 WITH THE REPORTED ISSUE OF ¿SYRINGES RECEIVED WITH FOREIGN PARTICLES, BLACK SPOT, HAIR PARTICLE, MARKETING DEFECTS, BLISTER LEAKAGE. THE DHR OF MATERIAL NUMBER 301866 AND LOT NUMBER 0214097 WAS CHECKED FOR ANY QUALITY NOTIFICATION AND NO QUALITY NOTIFICATION WAS RECORDED ON THIS LOT. (PLEASE NOTE THAT THE PIR FORM MENTIONED 0214907 WHILE THE CORRECT BATCH THAT WAS SUPPLIED TO THE CUSTOMER AND THE SAMPLES RECEIVED ARE OF 0214097). SIXTEEN SAMPLES WERE RECEIVED FROM THE CUSTOMER AND WERE USED FOR INVESTIGATION OF THE REPORTED DEFECTS. THE INVESTIGATING TEAM ALSO USED THE RETENTION SAMPLES OF MATERIAL CODE 301866 AND LOT NUMBER 0214097 FOR INVESTIGATING THE REPORTED DEFECT. THE SAMPLES RECEIVED FOR INVESTIGATION HAVE CONFIRMED THE DEFECTS REPORTED BY THE CUSTOMER. THERE ARE MULTIPLE DEFECTS REPORTED IN THIS COMPLAINT. THE PROBABLE ROOT CAUSE AND THE ACTION PLAN FOR EACH IS AS FOLLOWS. THE PROBABLE ROOT CAUSES ARE: 1. BLISTER DAMAGE COMPLAINT. - WORN OUT BUSH AND DIFFERENCE IN CHAIN POSITIONS AT IN AND OUT. 2. FOREIGN MATTER (BLACK SPOT, HAIR, LOOSE PARTICLE) ¿ DRAGGING OF BINS ON FLOOR AND OVERFILLING OF SYRINGE HOPPER 3. MARKING DEFECT- ADDED A CHECK TOGGLE ARM AND REPLACED A AND B STAMPING AND PRINTING STATION. ACTIONS FOR BLISTER DAMAGE COMPLAINTS: ALL WORN OUT BUSH TO BE REPLACED WITH NEW BUSH AT BOTTOM WEB LOADING STATION DIFFERENCE IN BOTH CHAIN DISTANCE AT IN AND OUT OF M/C TO BE REDUCED TO MINIMUM DIFFERENCE SPROCKET TO OPEN CHANGE CLITS AT LAMINATE FEEDING STATION TO BE REPLACED BECAUSE THEY ARE WORN OUT STATIC DISCHARGER TO BE FIXED ON FLEXI#1 MACHINE AFTER NEEDLE LOADER TO ELIMINATE STATIC CHARGE PRODUCED AFTER NEEDLE LOADER SENSOR TO BE PROVIDED AT BOTTOM WEB STATION TO DETECT THE ROLL DIAMETER AND ADJUST MOTOR SPEED ACCORDINGLY ON FLEXI#1 SENSOR TO BE PROVIDED AT TOP WEB STATION TO DETECT ROLL DIAMETER AND ADJUST MOTOR SPEED ACCORDINGLY ON FLEXI#1 ACTIONS FOR FOREIGN MATTER (BLACK SPOT, HAIR, LOOSE PARTICLE): TROLLEY TO BE DESIGNED TO CARRY BINS FROM M&A MACHINE TO BLISTER PACK MACHINE 2 BINS (10000 SYRINGES) WILL BE FILLED IN HOPPER AT A TIME AND MAXIMUM LEVEL INDICATED IN HOPPER TO BE MARKED TO UPDATE PREVENTIVE MAINTENANCE CHECKLIST (M-F- 035) TO INCLUDE CLEANING OF SYRINGE LOADER PARTS SUCH AS FINGERS, PLATE MARKING DEFECT ¿ ADDED A CHECK TOGGLE ARM AND REPLACED A AND B STAMPING AND PRINTING STATION. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT (B)(4) DISCARDIT II 2 ML WITH 25G X 1 EXPERIENCED FOREIGN MATTER IN THE FLUID PATH, SCALE MARKING ISSUES, AND DAMAGED UNIT PACKAGING THAT RESULTED IN BREACHED STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES RECEIVED WITH FOREIGN PARTICLES, BLACK SPOT, HAIR PARTICLE, MARKETING DEFECTS, NO NEEDLE, DOUBLE NEEDLE , BLISTER LEAKAGE, DAMAGED SYRINGE.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: 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, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0214097. MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. DEVICE MANUFACTURE DATE: 2020-08-01. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 19,390 DISCARDIT II 2 ML WITH 25G X 1 EXPERIENCED FOREIGN MATTER IN THE FLUID PATH, SCALE MARKING ISSUES, AND DAMAGED UNIT PACKAGING THAT RESULTED IN BREACHED STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES RECEIVED WITH FOREIGN PARTICLES, BLACK SPOT, HAIR PARTICLE, MARKETING DEFECTS, NO NEEDLE, DOUBLE NEEDLE , BLISTER LEAKAGE, DAMAGED SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107874 DISCARDIT II 2 ML WITH 25G X 1 SYRINGE FMF BECTON DICKINSON SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1