BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7902502 · Received September 24, 2018

    Report

    Report Number
    1213809-2018-00615
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    September 3, 2018
    Report Date
    November 27, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010295
    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: FOURTEEN LOOSE 10ML ASSEMBLED SYRINGES WERE RECEIVED AND REPORTED TO BE FROM BATCH #7150678 AND 7332852 (P/N 301029). THE SAMPLES WERE IN SEPARATE SAMPLE BAGS. EACH BAG WAS IDENTIFIED WITH THE COMPLAINT#, BATCH # AND DESCRIPTION OF DEFECT. THE SAMPLES WERE VISUALLY EVALUATED. 7332852 ¿ ¿PARTICULATE¿ - TWO SYRINGES. BOTH SYRINGES WITH SINGLE BLACK FM SPOTS ON BARREL EXTERIOR OUTSIDE THE SCALE MARKINGS. THE FM APPEARS TO BE INK. IT IS CONSIDERED TO BE A COSMETIC DEFECT AND IS ACCEPTABLE PER PRODUCT SPECIFICATION. 7150678 ¿ ¿PARTICULATE¿ ¿ TWO SYRINGES. NO FM WAS FOUND ON 1 SYRINGE. UNIDENTIFIED FOREIGN MATTER PARTICULATE LARGER THAN LEVEL 3 IN SIZE WAS FOUND ON THE STOPPER IN THE FLUID PATH OF 1 SYRINGE. IT WAS SENT FOR FTIR ANALYSIS TO OBTAIN MORE DETAILS. THE FM OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS COMPLETE ON THE RING OF MATERIAL OBSERVED ON THE STOPPER OF ONE SAMPLE RECEIVED AND ON THE PIECES OF MATERIAL OBSERVED ON THE STOPPER OF THE OTHER SYRINGE RECEIVED. A SMALL PORTION OF EACH OF THESE MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE ANALYSIS SHOWS THAT THE RING OF MATERIAL IS MOST LIKELY CALCIUM CARBONATE MIXED WITH SILICONE AND THE PIECE OF MATERIAL IS MOST LIKELY CELLULOSE MIXED WITH SILICONE. 7332852 ¿ ¿DAMAGE¿ ¿ TWO SYRINGES. 7150678 ¿ ¿DAMAGE¿ ¿ TWO SYRINGES. ALL FOUR SYRINGES WERE FOUND TO HAVE DAMAGE TO THE PLUNGER ROD RIB. THE OBSERVED DAMAGE IS REJECTABLE PER PRODUCT SPECIFICATION. 7332852 ¿ ¿PRINT¿ ¿ TWO SYRINGES. TWO SYRINGES WERE FOUND TO HAVE MISSING PRINT BETWEEN THE 3ML AND 8ML MARKINGS. THE PRINT APPEARS TO HAVE BEEN SCRATCHED OFF. THE OBSERVED MISSING PRINT IS REJECTABLE PER PRODUCT SPECIFICATION. 7150678 ¿ ¿PRINT¿ ¿ TWO SYRINGES. TWO SYRINGES WERE FOUND TO HAVE MISSING PRINT BETWEEN THE 6ML AND 10ML MARKINGS. THE PRINT APPEARS TO HAVE BEEN SCRATCHED OFF. THE OBSERVED MISSING PRINT IS ACCEPTABLE ON 1 SYRINGE AND REJECTABLE ON 1 SYRINGE PER PRODUCT SPECIFICATION. 7332852 ¿ ¿MIS-ALIGNED GASKET¿ ¿ TWO SYRINGES WITH DISTORTED STOPPERS. THE DISTORTED STOPPERS OBSERVED ARE CONSIDERED REJECTABLE PER PRODUCT SPECIFICATION. CONCLUSION: ¿PARTICULATE¿ ¿ POTENTIAL ROOT CAUSE FOR THE LOOSE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MATERIAL HANDLING AND ASSEMBLY PROCESS. ¿DAMAGE¿ AND ¿MIS-ALIGNED GASKET¿ ¿ POTENTIAL ROOT CAUSE FOR THE DAMAGED PLUNGER ROD AND DISTORTED STOPPER OBSERVED IS ASSOCIATED WITH THE ASSEMBLY PROCESS. ¿PRINT¿ ¿ POTENTIAL ROOT CAUSE FOR THE PRINT DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. CONCLUSION(S): ¿PARTICULATE¿ ¿ OUT OF 4 SYRINGES RECEIVED FOR ¿PARTICULATE¿ DEFECT, 3 WERE FOUND TO BE WITHIN THE ACCEPTABLE LIMITS. THE FM WAS SMALL, OUTSIDE THE FLUID PATH AND CONSIDERED A COSMETIC DEFECT. ONLY 1 WAS CONSIDERED REJECTABLE PER PRODUCT SPECIFICATION. THE PARTICULATE DEFECTS OCCUR AT LOW OCCURRENCE LEVELS AND ARE TYPICALLY WELL WITHIN THE ACCEPTABLE QUALITY LIMITS. NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. ¿DAMAGE¿ AND ¿MIS-ALIGNED GASKET¿ ¿ 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. ¿PRINT¿ ¿ 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. DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE LUER-LOK¿ TIPS HAD FOREIGN MATTER, DAMAGE, VOLUMETRIC INACCURACY, AND MIS-ALIGNED GASKETS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7150678, MEDICAL DEVICE EXPIRATION DATE: 05/31/2022, DEVICE MANUFACTURE DATE: 05/30/2017; MEDICAL DEVICE LOT #: 7332852, MEDICAL DEVICE EXPIRATION DATE: 11/30/2022, DEVICE MANUFACTURE DATE: 11/28/2017. (B)(6). 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 BD SYRINGE LUER-LOK¿ TIPS HAD FOREIGN MATTER, DAMAGE, VOLUMETRIC INACCURACY, AND MIS-ALIGNED GASKETS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744898 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 00382903010295

    Patients

    Seq Age Sex Outcome Treatment
    1 Other