BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PLASTIPAK SYRINGE

    MDR report key: 7706495 · Received July 20, 2018

    Report

    Report Number
    1213809-2018-00433
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    July 2, 2018
    Report Date
    August 28, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIRTEEN LOOSE 1ML ASSEMBLED SYRINGES WERE RECEIVED AND REPORTED TO BE FROM BATCH #7121638 AND 7215974 (P/N 309648). THE SAMPLES WERE IN SEPARATE SAMPLE BAGS (SIX SAMPLE BAGS). EACH BAG WAS IDENTIFIED WITH THE COMPLAINT#, BATCH # AND DESCRIPTION OF DEFECT. THE SAMPLES WERE VISUALLY EVALUATED. 7121638 ¿PARTICULATE¿ TWO SYRINGES. LOOSE WHITE FOREIGN MATTER LEVEL 1 IN SIZE ON BARREL EXTERIOR APPEARS TO BE PLASTIC DUST. LEVEL 1 FOREIGN MATTER IS ACCEPTABLE PER PRODUCT SPECIFICATION. 7121638 ¿DAMAGE¿ THREE SYRINGES. ALL SYRINGES HAVE MAJOR DAMAGE TO BARREL EXTERIOR. TWO ALSO HAVE MISSING PRINT AND ONE HAS A DAMAGE PLUNGER ROD. THE DAMAGE OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. 7121638 ¿PRINT¿ TWO SYRINGES. BOTH SYRINGES HAVE PRINT IMPERFECTIONS AROUND THE GRAD LINES. ONE SYRINGE WITH PARTS OF GRAD LINES MISSING AROUND 0.9ML AND ONE SYRINGE WITH PARTS OF GRAD LINES MISSING AROUND 0.1 AND 0.3ML. THE AMOUNT OF PRINT MISSING DOES NOT EXCEED 50% OF ANY ONE CHARACTER. THE MISSING PRINT OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. 7215974 ¿PARTICULATE¿ TWO SYRINGES. BOTH SYRINGES APPEAR TO HAVE ADHESIVE RESIDUE ON BARREL EXTERIOR, APPARENTLY FROM A REMOVED TAPE OR A LABEL, WHICH ARE NOT PART OF BD MANUFACTURING PROCESS. ONE SYRINGE HAD A FEW LEVEL 1 EMBEDDED PARTICLES IN THE BARREL WALL, WHICH ARE ACCEPTABLE PER PRODUCT SPECIFICATION. NO OTHER MANUFACTURING DEFECTS WERE OBSERVED. 7215974 ¿DAMAGE¿ TWO SYRINGES. ONE SYRINGE WITH A MISSING STOPPER. ONE SYRINGE WITH DAMAGE TO BARREL EXTERIOR INCLUDING BARREL FLANGE. THE MISSING STOPPER AND DAMAGE OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. 7215974 ¿PRINT¿ TWO SYRINGES. ONE SYRINGE HAS SOME OF THE PRINT MISSING AT THE 0.7ML GRAD LINE. THE SECOND SYRINGE HAS SOME OF THE PRINT MISSING AT THE MINOR GRAD LINES AROUND 0.3ML. THE AMOUNT OF MISSING PRINT DOES NOT EXCEED 50% OF ANY ONE CHARACTER. THE MISSING PRINT OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. A 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. INVESTIGATION CONCLUSION: PROBABLY ROOT CAUSE. 1. ¿DAMAGE¿ POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL AND MISSING STOPPER OBSERVED IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 2. ¿PARTICULATE¿ POTENTIAL ROOT CAUSE FOR THE LOOSE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MATERIAL HANDLING AND ASSEMBLY PROCESS. 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. 3. ¿PRINT¿ POTENTIAL ROOT CAUSE FOR THE PRINT DEFECTS IS ASSOCIATED WITH THE PRINTING PROCESS CORRECTIVE AND PREVENTIVE ACTION . 1. ¿PARTICULATE¿ THE DEFECTS OBSERVED IN THE SAMPLES RECEIVED WERE CONSIDERED COSMETIC AND ACCEPTABLE PER PRODUCT SPECIFICATION. FURTHERMORE, THEY OCCUR AT LOW OCCURRENCE LEVELS AND ARE TYPICALLY WELL WITHIN THE ACCEPTABLE QUALITY LIMITS. NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. 2. ¿DAMAGE¿ 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. 3. ¿PRINT¿ THE DEFECTS OBSERVED IN THE SAMPLES RECEIVED WERE CONSIDERED COSMETIC AND ACCEPTABLE PER PRODUCT SPECIFICATION. THEY DO NOT AFFECT THE FIT, FORM OR FUNCTION OF THE FINAL PRODUCT. THE VOLUMETRIC ACCURACY IS NOT AFFECTED BY THESE IMPERFECTIONS. 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. THE SAMPLES RECEIVED SHOULD BE REPRESENTATIVE OF THE OVERALL DEFECTS REPORTED BY THE CUSTOMER (¿BD DEFECTS¿ PDF REPORT). HOWEVER, BASED ON THE EVALUATION PERFORMED, IT APPEARS THERE IS A DISCREPANCY IN THE ACCEPTANCE CRITERIA. OUR RECOMMENDATION IS TO REACH OUT TO THE CUSTOMER TO ALIGN PRODUCT ACCEPTANCE CRITERIA AND CUSTOMER EXPECTATIONS. CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER . DEVICE SINGLE USE?: NO . DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ PLASTIPAK SYRINGE HAD "DAMAGE, INCLUSIONS, AND PRINT ISSUES". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7121638; MEDICAL DEVICE EXPIRATION DATE: 04/30/2022; DEVICE MANUFACTURE DATE: 05/01/2017; MEDICAL DEVICE LOT #: 7215974; MEDICAL DEVICE EXPIRATION DATE: 07/31/2022; DEVICE MANUFACTURE DATE: 08/03/2017. 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¿ PLASTIPAK SYRINGE HAD "DAMAGE, INCLUSIONS, AND PRINT ISSUES". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549995 BD¿ PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other