BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 13256179 · Received January 13, 2022

    Report

    Report Number
    1213809-2021-00862
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 10, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0071629, MEDICAL DEVICE EXPIRATION DATE: 02/28/2025, DEVICE MANUFACTURE DATE: 03/19/2020. MEDICAL DEVICE LOT #: 1005797, MEDICAL DEVICE EXPIRATION DATE: 12/31/2025, DEVICE MANUFACTURE DATE: 01/20/2021. MEDICAL DEVICE LOT #: 1005805, MEDICAL DEVICE EXPIRATION DATE: 12/31/2025, DEVICE MANUFACTURE DATE: 01/24/2021. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 0240776. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT #1036006. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0071629, MEDICAL DEVICE EXPIRATION DATE: 02/28/2025, DEVICE MANUFACTURE DATE: 03/19/2020. MEDICAL DEVICE LOT #: 0142212, MEDICAL DEVICE EXPIRATION DATE: 04/30/2025, DEVICE MANUFACTURE DATE: 05/28/2020. MEDICAL DEVICE LOT #: 0127987, MEDICAL DEVICE EXPIRATION DATE: 04/30/2025, DEVICE MANUFACTURE DATE: 03/13/2020. MEDICAL DEVICE LOT #: 0142212, MEDICAL DEVICE EXPIRATION DATE: 04/30/2025, DEVICE MANUFACTURE DATE: 05/28/2020. MEDICAL DEVICE LOT #: 1152292, MEDICAL DEVICE EXPIRATION DATE: 05/31/2026, DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: FIFTY-ONE LOOSE 10ML SYRINGES WERE RECEIVED (P/N 301029). THROUGH VISUAL INSPECTION, MULTIPLE DEFECTS EMBEDDED FOREIGN MATTER, MISSING PLUNGER ROD, DISTORTED STOPPER, DAMAGED BARREL, DAMAGED PLUNGER ROD, MISSING STOPPER AND SCALE MARKING DEFECTS WERE OBSERVED. 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. POTENTIAL ROOT CAUSE FOR THE MISSING PLUNGER ROD, DISTORTED STOPPER, DAMAGED BARREL NEAR FLANGE, DAMAGED PLUNGER ROD, AND MISSING STOPPER DEFECT ARE ALL ASSOCIATED WITH THE ASSEMBLY PROCESS. POTENTIAL ROOT CAUSE FOR THE SCALE MARKING DEFECTS AND BARREL DAMAGE ON SAMPLES WITH SCALE MARKING ISSUES IS ASSOCIATED WITH THE MARKING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCHES 0071629, 0127987, 0142212, 1005797, 1005805, AND 1152292 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE DEFECTS WERE FOUND FROM A COLLECTION OF BD SYRINGE LUER-LOK¿ TIPS. DEFECTS INCLUDE BARREL/FLANGE DAMAGE (9 OCCURRENCES), MISSING SCALE MARKINGS (2 OCCURRENCES), ILLEGIBLE/BLURRED SCALE MARKINGS (26 OCCURRENCES), SCALE MARKINGS PERMANENCY (13 OCCURRENCES), AND PLUNGER ROD DAMAGE (5 OCCURRENCES). THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IT IS IMPOSSIBLE TO DETERMINE HOW MANY SYRINGES COME FROM THE PARTICULAR BATCH#. 6 SYRINGES WITH DEFORMATION, 2 UNPRINTED, 10 SYRINGES INCOMPLETE/NO PLUNGER - LOT: 0071629/1005797/1005805; 12 SYRINGES BAD PRINT, 6 SYRINGES INK SPLATTER, 1 SYRINGE CONTAMINATION TOP. - LOT: 0240776/1036006; 1 SYRINGE BAD PRINT, 7 SYRINGES INK SPLASHES, 3 BAD PLUNGER - LOT: 0071629-0142212-0127987; 13 SYRINGES BAD PRINT, 1 WITHOUT RUBBER, 3 BROKEN, 2 WITH PLUNGER CROOKED, 3 CONTAMINATED/INK - LOT: 0142212/1152292."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE DEFECTS WERE FOUND FROM A COLLECTION OF BD SYRINGE LUER-LOK¿ TIPS. DEFECTS INCLUDE BARREL/FLANGE DAMAGE (9 OCCURRENCES), MISSING SCALE MARKINGS (2 OCCURRENCES), ILLEGIBLE/BLURRED SCALE MARKINGS (26 OCCURRENCES), SCALE MARKINGS PERMANENCY (13 OCCURRENCES), AND PLUNGER ROD DAMAGE (5 OCCURRENCES). THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "IT IS IMPOSSIBLE TO DETERMINE HOW MANY SYRINGES COME FROM THE PARTICULAR BATCH #. 6 SYRINGES WITH DEFORMATION, 2 UNPRINTED, 10 SYRINGES INCOMPLETE/NO PLUNGER - LOT: 0071629/1005797/1005805. 12 SYRINGES BAD PRINT, 6 SYRINGES INK SPLATTER, 1 SYRINGE CONTAMINATION TOP. - LOT: 0240776/1036006. 1 SYRINGE BAD PRINT, 7 SYRINGES INK SPLASHES, 3 BAD PLUNGER - LOT: 0071629-0142212-0127987. 13 SYRINGES BAD PRINT, 1 WITHOUT RUBBER, 3 BROKEN, 2 WITH PLUNGER CROOKED, 3 CONTAMINATED/INK - LOT: 0142212/1152292."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014592 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown