BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7986862 · Received October 19, 2018

    Report

    Report Number
    1213809-2018-00680
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    October 1, 2018
    Report Date
    December 6, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: SAMPLES OF 10ML SYRINGES FROM 3 REPORTED BATCHES FOR VARIOUS REPORTED DEFECTS WERE RECEIVED AND EVALUATED: 6 SAMPLES FROM BATCH #7150678, 6 FROM BATCH #7278957 AND 6 FROM BATCH #7332852, ALL (B)(4). 7150678 ¿ PARTICULATE ¿ 2 SAMPLES WERE RECEIVED. THE SYRINGES WERE IN BREAKOUT STOPPER POSITION. EACH SYRINGE¿S STOPPER WAS OBSERVED TO HAVE A LARGE PIECE OF FLAT BROWN FIBROUS FOREIGN MATTER, LARGER THAN LEVEL 3 IN SIZE, IN THE FLUID PATH. THE FOREIGN MATTER APPEARED TO BE CARDBOARD AND IS REJECTABLE PER PRODUCT SPECIFICATION. 7150678 ¿ DAMAGE ¿ 2 SAMPLES WERE RECEIVED. THE BARRELS OF BOTH SYRINGES WERE FOUND TO HAVE DAMAGE AROUND THE 6ML MARKINGS. ONE OF THE SYRINGES¿ PLUNGER ROD WAS ALSO DAMAGED IMMEDIATELY UNDERNEATH THE BARREL DAMAGE AS WELL. THE DAMAGE IS REJECTABLE PER PRODUCT SPECIFICATION. 7150678 ¿ PRINT ¿ 2 SAMPLES WERE RECEIVED. BOTH BARRELS HAD PORTIONS OF THE CENTER OF THE GRADUATED LINES SCRATCHED OFF BETWEEN 9ML AND 4ML ON ONE BARREL AND 9ML AND 1ML ON ANOTHER BARREL. ALL OF THE NUMERICAL MARKINGS WERE PRESENT AND LEGIBLE. THE AMOUNT OF GRAD LINES PRINT MISSING WAS LESS THAN 50% OF ANY ONE LINE. THEREFORE, THE OVERALL PRINT QUALITY IS CONSIDERED ACCEPTABLE PER PRODUCT SPECIFICATION. 7278957 ¿ PARTICULATE - 2 SAMPLES WERE RECEIVED. THE SYRINGES WERE IN BREAKOUT STOPPER POSITION. BOTH SYRINGES HAD LARGE FIBROUS BROWN PARTICLES, LARGER THAN LEVEL 3 IN SIZE, IN THE FLUID PATH ON TOP OF THE STOPPER AS WELL AS EXTENDING ON THE SIDE OF THE STOPPERS TO BETWEEN THE STOPPER RIBS. THE FOREIGN MATTER APPEARED TO BE CARDBOARD AND IS REJECTABLE PER PRODUCT SPECIFICATION. 7278957 ¿ DAMAGE ¿ 2 SAMPLES WERE RECEIVED. THE SYRINGES WERE IN BOTTOM OUT POSITION. BOTH SYRINGES WERE OBSERVED TO HAVE DAMAGE TO PLUNGER ROD RIBS APPROXIMATELY HALF WAY UP THE PLUNGER ROD FROM THE THUMB REST, COINCIDING WITH THE 8ML MARKINGS ON THE BARREL. THE DAMAGE OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. 7278957 ¿ PRINT ¿ 2 SAMPLES WERE RECEIVED. BOTH BARRELS HAD PORTIONS OF THE CENTER OF THE GRADUATED LINES SCRATCHED OFF. ONE SYRINGE BARREL HAD PORTIONS OF GRAD LINES MISSING BETWEEN 9ML AND 2ML. HOWEVER, LESS THAN 50% OF ANY ONE LINE WAS MISSING ¿ THEREFORE PRINT QUALITY IS CONSIDERED ACCEPTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE BARREL HAD PORTIONS OF GRAD LINES MISSING BETWEEN 10ML AND 2ML WITH MORE THAN 50% OF AT LEAST ONE LINE MISSING. THEREFORE, PRINT QUALITY IS REJECTABLE PER PRODUCT SPECIFICATION. 7332852 ¿ PARTICULATE ¿ 2 SAMPLES WERE RECEIVED. THE SYRINGES WERE IN BREAKOUT STOPPER POSITION. EACH SYRINGE¿S STOPPER WAS OBSERVED TO HAVE A LARGE PIECE OF FLAT BROWN FIBROUS FOREIGN MATTER, LARGER THAN LEVEL 3 IN SIZE, IN THE FLUID PATH. THE FOREIGN MATTER APPEARED TO BE CARDBOARD AND IS REJECTABLE PER PRODUCT SPECIFICATION. 7332852 ¿ DAMAGE ¿ 2 SAMPLES WERE RECEIVED. BOTH SYRINGES HAD DAMAGE TO THEIR PLUNGER RODS¿ RIBS. WITH THEIR STOPPERS AT BOTTOM OUT POSITION THE DAMAGE WAS OBSERVED APPROXIMATELY HALF WAY UP ON ONE SYRINGE COINCIDING WITH THE 8ML MARKING ON THE BARREL. ON THE OTHER SYRINGE 2 OPPOSING RIBS WERE CRACKED APPROXIMATELY IN THE MIDDLE OF THE PLUNGER ROD. 7332852 ¿ PRINT ¿ 2 SAMPLES WERE RECEIVED. BOTH SAMPLES HAD PORTIONS OF THE PRINT MISSING. ONE BARREL HAD GRAD LINES BETWEEN 2ML AND 9ML MARKINGS AS WELL AS NUMERALS 6, 7 AND 9 SCRATCHED OFF. ONE BARREL HAD PORTIONS OF GRAD LINES MISSING BETWEEN 4ML AND 7ML. THE AMOUNT OF PRINT MISSING OR ILLEGIBLE WAS MORE THAN 50% OF AT LEAST ONE LINE OR ITEM ON BOTH BARRELS. THEREFORE BOTH PRINT CONDITIONS WERE REJECTABLE PER PRODUCT SPECIFICATION. DEVICE HISTORY RECORD REVIEW: FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE: 1. ¿INCLUSIONS¿ ¿ POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. 2. ¿PARTICULATE¿ ¿ POTENTIAL ROOT CAUSE FOR THE LOOSE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MATERIAL HANDLING AND ASSEMBLY PROCESS. 3. ¿DAMAGE¿ ¿ POTENTIAL ROOT CAUSE FOR THE DAMAGED PLUNGER ROD, BARREL AND DISTORTED STOPPER OBSERVED IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 4. ¿PRINT¿ ¿ POTENTIAL ROOT CAUSE FOR THE PRINT DEFECTS IS ASSOCIATED WITH THE PRINTING PROCESS. CORRECTIVE ACTIONS: 1. ¿INCLUSIONS¿ ¿ IT IS IMPORTANT TO NOTE, THAT THIS TYPE OF DEFECT IS COSMETIC, OCCURS AT VERY LOW FREQUENCY AND DOES NOT POSE RISK TO THE CUSTOMER. NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. 2. ¿PARTICULATE¿ ¿ OUT OF 8 SYRINGES RECEIVED FOR ¿PARTICULATE¿ DEFECT 6 WERE FOUND TO BE WITHIN THE ACCEPTABLE LIMITS. THE FOREIGN MATTER WAS SMALL, OUTSIDE THE FLUID PATH AND CONSIDERED A COSMETIC DEFECT. ONLY 2 WERE CONSIDERED REJECTABLE PER PRODUCT SPECIFICATION. NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. 3. ¿DAMAGE¿ ¿ OUT OF 6 SYRINGES RECEIVED, 2 HAD MINOR COSMETIC DAMAGE, WHERE THERE WAS NO EFFECT AS TO THE FIT, FORM OR FUNCTION OF THE PRODUCT AND ARE THEREFORE ACCEPTABLE PER PRODUCT SPECIFICATION. 4 OUT OF 6 HAD REJECTABLE DEFECTS. THESE DEFECTS TYPICALLY OCCUR AT EXTREMELY LOW FREQUENCY DURING THE HIGH SPEED MANUFACTURING PROCESS AND ARE USUALLY ISOLATED INCIDENTS. CONTROLS ARE IN PLACE TO ISOLATE AND CONTAIN DEFECTS TO ENSURE THE QUALITY OF THE FINAL PRODUCT. HOWEVER, A FEW PIECES WITH DEFECTS MAY ESCAPE DETECTION. NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. 4. ¿PRINT¿ ¿ OUT OF 8 SYRINGES RECEIVED FOR ¿PRINT¿ DEFECTS 6 HAD MINOR COSMETIC PRINT DEFECTS AND ARE WITHIN THE ACCEPTABLE PRINT QUALITY LEVELS. ONLY 2 WERE CONSIDERED REJECTABLE PER OUR PRODUCT SPECIFICATION. THESE TYPE OF DEFECTS ARE RARE BUT MAY OCCUR AT LOW FREQUENCY DURING THE HIGH SPEED MANUFACTURING PROCESS. CONTROLS ARE IN PLACE THAT INCLUDE PERIODIC PRINT QUALITY CHECKS AND PRINT PAD CHANGES TO ENSURE CONSISTENT PRINT QUALITY. NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. CONTROLS ARE IN PLACE TO ENSURE CONTAINMENT OF DEFECTS AND QUALITY OF THE FINAL PRODUCT. THEY INCLUDE PERIODIC IN-PROCESS INSPECTIONS AT VARIOUS STAGES OF MANUFACTURING. IN ADDITION, REGARDING CARDBOARD FOREIGN MATTER: THE BATCHES INVOLVED ARE FROM 2017. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED SINCE THEN THAT INCLUDED ELIMINATING CARDBOARD AND WOOD FROM ALL MANUFACTURING AREAS. NO ADDITIONAL ACTIONS ARE RECOMMENDED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE LUER-LOK¿ TIP CONTAINED FOREIGN MATTER, HAD INCLUSIONS AND WAS DAMAGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7150678, EXPIRATION DATE: 2022-05-31, MANUFACTURE DATE: 2017-05-30. MEDICAL DEVICE LOT #: 7278957, EXPIRATION DATE: 2022-09-30, MANUFACTURE DATE: 2017-10-05. MEDICAL DEVICE LOT #: 7332852, EXPIRATION DATE: 2022-11-30, MANUFACTURE DATE: 2017-11-28. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SYRINGE LUER-LOK¿ TIP CONTAINED FOREIGN MATTER, HAD INCLUSIONS AND WAS DAMAGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826007 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other