BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE

    MDR report key: 9819193 · Received March 11, 2020

    Report

    Report Number
    1213809-2020-00183
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 20, 2020
    Report Date
    March 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : THREE PHOTOS WERE RECEIVED AND EVALUATED FOR CATALOG 3010127 LOTS 9210553 AND 9210552. THE PHOTOS DEPICTED ONE SYRINGE WITH OVER 20 SMALL INK SPOTS POSITIONED DIAGONALLY ACROSS THE BARREL OUTSIDE THE SCALE MARKINGS. THESE ARE CONTACT INK SMEARS AND ARE A COSMETIC DEFECT. HOWEVER, THE NUMBER OF SPOTS IS REJECTABLE PER PRODUCT SPECIFICATION. ONE BARREL WAS OBSERVED TO HAVE GRAY FOREIGN MATTER BETWEEN THE FLANGE AND BARREL WALL, OUTSIDE THE FLUID PATH AND APPEARED TO BE ON THE OUTSIDE OF THE BARREL AS WELL. IT WAS NOT CLEAR WHETHER THE FM WAS LOOSE OR EMBEDDED. THE SIZE WAS LARGER THAN LEVEL 3 AND REJECTABLE PER SPECIFICATION. TWO BARRELS WERE OBSERVED TO HAVE BROWN FOREIGN MATTER ¿ ONE AT THE LUER COLLAR AND BARREL WALL FROM UNKNOWN MOLD #, AND ONE AT THE BARREL FLANGE AND THE WALL FROM MOLD C-210 CAV 31. THE FM APPEARED TO BE EMBEDDED BURNT PLASTIC. THE SIZE OF FM ALSO APPEARED TO BE REJECTABLE PER PRODUCT SPECIFICATION. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUES. THE EMBEDDED FM 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. PER PROCEDURE, AFTER START UP, ALL MOLDED PARTS ARE SCRAPPED UNTIL NO DEGRADED PLASTIC IS OBSERVED. IF THIS IS NOT PERFORMED THOROUGHLY A PIECE WITH THIS CONDITION CAN GET THROUGH. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. POTENTIAL ROOT CAUSE FOR THE INK SMEARS DEFECT IS ASSOCIATED WITH THE SCALE MARKING PROCESS. IN ADDITION, A POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 9210552 AND 9210553 BATCH 9210553 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. IN ADDITION, BATCH 9210552 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGES WERE FOUND WITH BROKEN PLUNGERS, FOREIGN INK SPOTS, AND SHARP MOLDING DEFECTS. LOT#'S 9210552 AND 9210553 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNSPECIFIED HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM POLISH TO ENGLISH: "FOR THE ORDERED QUANTITY OF 16800 PCS WITH LOT NUMBER 9210552 (ARTICLE NO. 301027) THERE WERE 66 DEFICIENCIES WITH POURING. FOR THE ORDERED QUANTITY OF 32200 PCS WITH LOT NUMBER 9210553 (ARTICLE NO. 301027) THERE WERE SHORTAGES OF 1500 PCS WITH INK SPOTS. FOR THE ORDERED QUANTITY OF 30400 PCS WITH LOT NUMBER 9088552 (ARTICLE NO. 301073) THERE WERE SHORTAGES 80 PCS WITH BROKEN PISTON."

    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 #: 9210552. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-29. MEDICAL DEVICE LOT #: 9210553. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-29. 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 BEFORE USE, THE BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGES WERE FOUND WITH BROKEN PLUNGERS, FOREIGN INK SPOTS, AND SHARP MOLDING DEFECTS. LOT#'S 9210552 AND 9210553 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNSPECIFIED HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "FOR THE ORDERED QUANTITY OF 16800 PCS WITH LOT NUMBER 9210552 (ARTICLE NO. 301027) THERE WERE 66 DEFICIENCIES WITH POURING. FOR THE ORDERED QUANTITY OF 32200 PCS WITH LOT NUMBER 9210553 (ARTICLE NO. 301027) THERE WERE SHORTAGES OF 1500 PCS WITH INK SPOTS. FOR THE ORDERED QUANTITY OF 30400 PCS WITH LOT NUMBER 9088552 (ARTICLE NO. 301073) THERE WERE SHORTAGES 80 PCS WITH BROKEN PISTON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285276 BD PLASTIC NON-STERILE LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other