BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7706343 · Received July 20, 2018

    Report

    Report Number
    1213809-2018-00434
    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
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION SUMMARY: TWENTY-SIX LOOSE 10ML ASSEMBLED SYRINGES WERE RECEIVE AND REPORTED TO BE FROM BATCH #7088992, 7150678, 7277752, 7237636 (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. 7088992 ¿ ¿INCLUSIONS¿ ¿ ONE EMBEDDED LIGHT BROWN PARTICLE LOCATED IN BARREL WALL NEAR 2ML GRAD LINE. THE OBSERVED FOREIGN MATTER IS LARGER THAN LEVEL 3 IN SIZE WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. 7088992 ¿ ¿DAMAGE¿ ¿ TWO SYRINGES. BOTH SYRINGES WERE FOUND TO HAVE DAMAGE TO THE PLUNGER ROD RIB. THE OBSERVED DAMAGE IS REJECTABLE PER PRODUCT SPECIFICATION. 7088992 ¿ ¿PARTICULATE¿ ¿ TWO SYRINGES. BOTH SYRINGES WERE FOUND TO HAVE LOOSE FOREIGN MATTER ON EXTERIOR OF BARREL LEVEL 1 IN SIZE. THE FOREIGN MATTER OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. 7150678 ¿ ¿PRINT¿ ¿ THREE SYRINGES. TWO SYRINGES WITH CONTACT INK SMEARS AND ONE SYRINGE WITH MISSING PRINT NEAR 7ML GRAD LINE. THE CONTACT SMEARS OBSERVED ARE CONSIDERED ACCEPTABLE PER PRODUCT SPECIFICATION. THE MISSING PRINT OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. 7150678 ¿ ¿INCLUSIONS¿ ¿ ONE SYRINGE WITH OFF WHITE PARTICLE EMBEDDED IN BARREL WALL. FOREIGN MATTER IS LEVEL 1 IN SIZE, WHICH IS ACCEPTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WITH TWO LIGHT BROWN PARTICLES EMBEDDED IN BARREL WALL APPROXIMATELY LEVEL 2 IN SIZE, WHICH IS ACCEPTABLE PER PRODUCT SPECIFICATION. 7150678 ¿ ¿PARTICULATE CONTAMINATION¿ ¿ TWO SYRINGES. ONE SYRINGE WITH BLACK GREASE LIKE FOREIGN MATTER ON PLUNGER RIB OUTSIDE OF FLUID PATH. THE FOREIGN MATTER IS APPROXIMATELY LEVEL 3 IN SIZE WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WITH BLACK PARTICULATE LOCATED NEAR BACK RIB OF STOPPER (OUTSIDE OF FLUID PATH). THE FOREIGN MATTER IS APPROXIMATELY LEVEL 1 IN SIZE WHICH IS ACCEPTABLE PER PRODUCT SPECIFICATION. 7150678 ¿ ¿DAMAGE¿ ¿ TWO SYRINGES. ONE SYRINGE WITH DISTORTED STOPPER. A DISTORTED STOPPER IS REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WITH DAMAGE TO PLUNGER RIBS, NEAR RETAINER, THE DAMAGE OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. 7237636 ¿ ¿PARTICULATE¿ - TWO SYRINGES. ONE SYRINGE WITH OFF WHITE PARTICLE, LEVEL THREE IN SIZE, LOCATED ON PLUNGER RIB. THE FOREIGN MATTER IS LOOSE AND OUTSIDE OF THE FLUID PATH. THE FOREIGN MATTER OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WITH BLACK SPECK ON BARREL WALL. THE SPECK APPEARS TO BE INK LEVEL 1 IN SIZE. THE FOREIGN MATTER OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. 7237636 ¿ ¿INCLUSIONS¿ - ONE SYRINGE WITH OFF WHITE PARTICLES EMBEDDED IN BARREL WALL NEAR 2ML GRAD LINE. THE FOREIGN MATTER OBSERVED IS LEVEL 2 IN SIZE WHICH IS CONSIDERED ACCEPTABLE PER PRODUCT SPECIFICATION. 7237636 ¿ ¿PRINT¿ ¿ THREE SYRINGES. ONE SYRINGE WITH CONTACT SMEARS AND ONE SYRINGE WITH SLIGHT MISSING PRINT LOCATED NEAR THE CENTER OF THE 7ML GRAD LINE. THESE PRINT DEFECTS ARE A YELLOW PRINT CONDITION AND CONSIDERED ACCEPTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WITH MISSING PRINT IN THE NUMBER 4. THE MISSING PRINT OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. 7277752 ¿ ¿PARTICULATE¿ - TWO SYRINGES WITH LEVEL TWO FOREIGN MATTER LOCATED IN THE NON-FLUID SIDE OF THE SYRINGE. THE FOREIGN MATTER IS OFF WHITE AND LOOSE NEAR THE PLUNGER ROD RIBS. THE FOREIGN MATER OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. 7277752 ¿ ¿DAMAGE¿ - TWO SYRINGES WITH MINOR DAMAGE TO PLUNGER RIBS NEAR THUMB REST. THE DAMAGE OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. 7277752 ¿ ¿PRINT¿ ¿ TWO SYRINGES WITH MISSING PRINT NEAR THE 7ML GRADLINE. THE MISSING PRINT OBSERVED DOES NOT EXCEED 50% OF THE PRINTED AREA. THE MISSING PRINT OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. DEVICE HISTORY RECORD: 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. ROOT CAUSE: 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 ACTION: 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE LUER-LOK¿ TIP HAD "DAMAGE, INCLUSIONS, PRINT ISSUE, AND FAULTY SEAL." 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. (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 #: 7088992, MEDICAL DEVICE EXPIRATION DATE: 04/30/2022, DEVICE MANUFACTURE DATE: 03/29/2017. MEDICAL DEVICE LOT #: 7150678, MEDICAL DEVICE EXPIRATION DATE: 05/31/2022, DEVICE MANUFACTURE DATE: 05/30/2017. MEDICAL DEVICE LOT #: 7277752, MEDICAL DEVICE EXPIRATION DATE: 09/30/2022, DEVICE MANUFACTURE DATE: 10/04/2017. 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 SYRINGE LUER-LOK¿ TIP HAD "DAMAGE, INCLUSIONS, PRINT ISSUE, AND FAULTY SEAL." NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547819 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other