BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 8753740 · Received July 2, 2019

    Report

    Report Number
    9610847-2019-00441
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 14, 2019
    Report Date
    September 24, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097013
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FIVE PLASTIC ZIP-LOCK BAGS CONTAINING LOOSE 1ML S/T SYRINGES WERE RECEIVED. EACH BAG WAS RECEIVED MARKED WITH A HANDWRITTEN LOT#. THE SAMPLES WERE VISUALLY EVALUATED. BAG 1. LOT #9091734. CONTAINED 7 SYRINGES TOTAL. 2 SYRINGES HAD A SLIGHT ROLL TO THE SCALE AND ALL 7 HAD CLOUDY TIPS. BAG 2. LOT #9091734. CONTAINED 5 SYRINGES TOTAL. ALL 5 SYRINGES HAD CLOUDY TIPS. BAG 3. LOT #9091734. CONTAINED 14 SYRINGES TOTAL. 5 SYRINGES HAD SKEW TO THE SCALE AND ALL OF THE SYRINGES HAD VARYING LEVELS OF CLOUDINESS IN THE TIPS. BAG 4. LOT #9037699. CONTAINED 7 SYRINGES TOTAL. ALL 7 SYRINGES HAD SLIGHT BLURRINESS OF THE SCALE MARKINGS AND 5 OF THE SYRINGES HAD CLOUDY TIPS. BAG 5. LOT #9037717. CONTAINED 11 SYRINGES TOTAL. 1 SYRINGE HAD SEVERE ABRASIONS TO THE TIP AND BOTTOM OF THE BARREL. THE DAMAGE WAS DIRECTIONAL FROM THE BARREL TOWARDS THE TIP AND REJECTABLE PER PRODUCT SPECIFICATION. 1 SYRINGE WAS OBSERVED TO HAVE JAMMED STOPPER. 9 SYRINGES WERE OBSERVED TO HAVE SLIGHT SKEW OR ROLL TO THE SCALE, WITH 3 OF THESE SYRINGES ALSO HAVING CLOUDY TIPS. THE SCALE MARKING IMPERFECTIONS OBSERVED, INCLUDING THE SLIGHT ROLL, SKEW, AND BLURRINESS OF THE SCALE MARKINGS IN THE SAMPLES RECEIVED WERE WITHIN THE PRODUCT SPECIFICATION AND ARE CONSIDERED COSMETIC DEFECTS AND ACCEPTABLE. CLOUDY TIP CONDITION IS COSMETIC AND ACCEPTABLE PER PRODUCT SPECIFICATION. THESE CONDITIONS DO NOT AFFECT THE FORM FIT OR FUNCTION OF THE DEVICE. FOUR PHOTOS WERE ALSO RECEIVED AND EVALUATED. THREE OF THE PHOTOS DEPICTED THE SAME SAMPLES RECEIVED ABOVE. ONE PHOTO DEPICTED A SINGLE 1ML SYRINGE SAMPLE NOT RECEIVED. THE SCALE MARKINGS ON THE PHOTO SAMPLE WERE OBSERVED TO BE THICK AND BLENDING INTO EACH OTHER. THIS TYPE OF PRINTING DEFECT IS REJECTABLE PER PRODUCT SPECIFICATION AS IT MAKES IT IMPOSSIBLE TO READ THE GRADUATED LINES CORRECTLY. CLOUDY TIPS ARE A RESULT OF NORMAL MOLDING PROCESS. OVER TIME A SMALL AMOUNT OF PLASTIC BUILD UP OR RESIDUE OCCURS IN THE MOLD CAUSING THIS DEFECT. IT IS REMEDIED BY POLISHING THE MOLD. THE CLOUDY TIP DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. POTENTIAL ROOT CAUSE FOR THE SCALE MARKING DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH EITHER THE ASSEMBLY PROCESS OR AT SOME POINT AFTER THE MATERIAL HAD LEFT THE PLANT AND PRIOR TO BEING PACKAGED. IT IS UNKNOWN WHICH SUBASSEMBLY BATCH EACH OF THE DEFECTIVE BARRELS CAME FROM. HOWEVER, THE DEFECTIVE RATE WOULD BE WELL WITHIN THE AQL. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 8261574, 8260524 AND 8298727 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    CORRECTION: AN ADDITIONAL LOT # WAS PROVIDED BY THE CUSTOMER. THE FOLLOWING INFORMATION HAS BEEN UPDATED: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 9000 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAYS FROM LOT # 9037716 HAD SCALE MARKINGS THAT WERE INCOMPLETE, BLURRY, AND/OR WERE NOT LEVEL AROUND THE BARREL, AND AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH "CLOUDY" FOREIGN MATTER IN THEM. 16500 TRAYS FROM LOT # 9037717 WERE FOUND WITH DEFECTIVE HUBS/STOPPERS, WHILE AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH FOREIGN MATTER IN THEM. 13200 TRAYS FROM LOT # 9091734 WERE ALSO FOUND WITH FOREIGN MATTER IN THEM, AS WERE AN UNKNOWN NUMBER OF TRAYS FROM LOT # 9037699. ALL DEFECTS FROM ALL LOTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPS VISUAL INSPECTORS HAVE BEEN DETECTING FREQUENT DEFECTS WITH THE 1ML BD SLIPTIP SYRINGES. THE GRADUATION MARKINGS PRINTED ON THE SYRINGES ARE EITHER INCOMPLETE, BLURRY, AND/OR TWISTED AROUND THE SYRINGE BARREL CAUSING INACCURATE READING OF THE FILL VOLUME. FURTHER, UPON CLOSER INSPECTION, OTHER DEFECTS HAVE BEEN IDENTIFIED AMONG THE REMAINING INVENTORY LOT# AS WELL (IE. CLOUDY SUBSTANCE INSIDE SYRINGE HUB, SEVERE ABRASION ON HUB, DEFECTIVE/INCOMPLETE SYRINGE PLUNGER). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9037716. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2019-03-01. MEDICAL DEVICE LOT #: 9037717. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2019-03-01. MEDICAL DEVICE LOT #: 9091734. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2019-05-15. MEDICAL DEVICE LOT #: 9037699. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2019-03-01. DEVICE AVAILABLE FOR EVAL?:YES. RETURNED TO MANUFACTURER ON: 2019-07-16. DEVICE RETURNED TO MANUF.? YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9000 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAYS FROM LOT # 9037716 HAD SCALE MARKINGS THAT WERE INCOMPLETE, BLURRY, AND/OR WERE NOT LEVEL AROUND THE BARREL, AND AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH "CLOUDY" FOREIGN MATTER IN THEM. 16500 TRAYS FROM LOT # 9037717 WERE FOUND WITH DEFECTIVE HUBS/STOPPERS, WHILE AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH FOREIGN MATTER IN THEM. 13200 TRAYS FROM LOT # 9091734 WERE ALSO FOUND WITH FOREIGN MATTER IN THEM, AS WERE AN UNKNOWN NUMBER OF TRAYS FROM LOT # 9037699. ALL DEFECTS FROM ALL LOTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPS VISUAL INSPECTORS HAVE BEEN DETECTING FREQUENT DEFECTS WITH THE 1ML BD SLIPTIP SYRINGES. THE GRADUATION MARKINGS PRINTED ON THE SYRINGES ARE EITHER INCOMPLETE, BLURRY, AND/OR TWISTED AROUND THE SYRINGE BARREL CAUSING INACCURATE READING OF THE FILL VOLUME. FURTHER, UPON CLOSER INSPECTION, OTHER DEFECTS HAVE BEEN IDENTIFIED AMONG THE REMAINING INVENTORY LOT# AS WELL (IE. CLOUDY SUBSTANCE INSIDE SYRINGE HUB, SEVERE ABRASION ON HUB, DEFECTIVE/INCOMPLETE SYRINGE PLUNGER).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9000 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAYS FROM LOT # 9037716 HAD SCALE MARKINGS THAT WERE INCOMPLETE, BLURRY, AND/OR WERE NOT LEVEL AROUND THE BARREL, AND AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH "CLOUDY" FOREIGN MATTER IN THEM. 16500 TRAYS FROM LOT # 9037717 WERE FOUND WITH DEFECTIVE HUBS/STOPPERS, WHILE AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH FOREIGN MATTER IN THEM. 13200 TRAYS FROM LOT # 9091734 WERE ALSO FOUND WITH FOREIGN MATTER IN THEM, AS WERE AN UNKNOWN NUMBER OF TRAYS FROM LOT # 9037699. ALL DEFECTS FROM ALL LOTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPS VISUAL INSPECTORS HAVE BEEN DETECTING FREQUENT DEFECTS WITH THE 1ML BD SLIPTIP SYRINGES. THE GRADUATION MARKINGS PRINTED ON THE SYRINGES ARE EITHER INCOMPLETE, BLURRY, AND/OR TWISTED AROUND THE SYRINGE BARREL CAUSING INACCURATE READING OF THE FILL VOLUME. FURTHER, UPON CLOSER INSPECTION, OTHER DEFECTS HAVE BEEN IDENTIFIED AMONG THE REMAINING INVENTORY LOT# AS WELL (IE. CLOUDY SUBSTANCE INSIDE SYRINGE HUB, SEVERE ABRASION ON HUB, DEFECTIVE/INCOMPLETE SYRINGE PLUNGER).

    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 #: 9037716, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2019-03-01, MEDICAL DEVICE LOT #: 9037717, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2019-03-01, MEDICAL DEVICE LOT #: 9091734, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2019-05-15. CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6), 00000 USA HAS BEEN USED AS A DEFAULT. 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 9000 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAYS FROM LOT # 9037716 HAD SCALE MARKINGS THAT WERE INCOMPLETE, BLURRY, AND/OR WERE NOT LEVEL AROUND THE BARREL, AND AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH "CLOUDY" FOREIGN MATTER IN THEM. 16500 TRAYS FROM LOT # 9037717 WERE FOUND WITH DEFECTIVE HUBS/STOPPERS, WHILE AN UNKNOWN NUMBER OF TRAYS FROM THE SAME LOT WERE FOUND WITH FOREIGN MATTER IN THEM. ADDITIONALLY, 13200 TRAYS FROM LOT # 9091734 WERE ALSO FOUND WITH FOREIGN MATTER IN THEM. ALL DEFECTS FROM ALL LOTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPS VISUAL INSPECTORS HAVE BEEN DETECTING FREQUENT DEFECTS WITH THE 1ML BD SLIPTIP SYRINGES. THE GRADUATION MARKINGS PRINTED ON THE SYRINGES ARE EITHER INCOMPLETE, BLURRY, AND/OR TWISTED AROUND THE SYRINGE BARREL CAUSING INACCURATE READING OF THE FILL VOLUME. FURTHER, UPON CLOSER INSPECTION, OTHER DEFECTS HAVE BEEN IDENTIFIED AMONG THE REMAINING INVENTORY LOT# AS WELL (IE. CLOUDY SUBSTANCE INSIDE SYRINGE HUB, SEVERE ABRASION ON HUB, DEFECTIVE/INCOMPLETE SYRINGE PLUNGER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550118 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE SECTION H.10. 30382903097013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other