BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SPINAL S/SU 22GA 5IN QUINCKE

    MDR report key: 8722227 · Received June 21, 2019

    Report

    Report Number
    2618282-2019-00206
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    June 3, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    UDI-DI
    30382904051489
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH SAMPLES FOR CATALOG 405148 LOT 8123938 TO INVESTIGATE FOR THIS RECORD. THE TWO SHELF CARTONS HAVE BEEN RECEIVED AND PER BILL OF MATERIAL, PRODUCT CONTAINS MOLDED CANNULA/STYLETS 5IN (127MM) AND 9IN SHIELDS. CATALOG NUMBERS COMPLIED WITH PRODUCT SPECIFICATION REQUIREMENTS. NEEDLE SIZE MEASURES THE LENGTH INDICATED AT SHELF CARTON AND BATCH DESCRIPTION. AS A RESULT, BD WAS NOT ABLE TO VERIFY THE REPORTED ISSUE. NO DISCREPANCIES OR NON-CONFORMANCE WERE IDENTIFIED WITH THE RETURNED SAMPLES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. THE SPINAL NEEDLES WITH QUINCKE POINTS AND STYLETS ARE USED IN VARIOUS SPINAL ANESTHESIA PROCEDURES. MATERIAL 405148 IS A 22 GAUGE NEEDLE WITH A 5-INCH INJECTION LENGTH. THIS NEEDLE IS A CLASS II, SINGLE USE DEVICE AND IT IS ETO STERILIZED. THE INTENDED USE FOR BD SPINAL NEEDLES IS THE ADMINISTRATION OF FLUIDS, TYPICALLY FOR SPINAL ANESTHESIA, AND/OR ASPIRATION OF CELLULAR MATERIAL. THE SPINAL NEEDLES (SUB-ASSEMBLY MATERIAL: 70005932) ARE ASSEMBLED ON THE TIC MACHINES AT THE BD JUNCOS SITE. ONCE FINAL INSPECTION OF THE ASSEMBLED NEEDLE IS APPROVED THE MATERIAL IS THEN PACKED ON THE MULTIVAC R-530 BLISTER PACKAGING MACHINE (SAP EQUIPMENT NUMBER: 40070728). THE PACKED NON-STERILE NEEDLES ARE AUTOMATICALLY PLACED WITHIN THE FORMED BLISTERS; 100% INSPECTION (10 SENSORS) IS PERFORMED FOR PRESENCE OF THE NEEDLE INSIDE THE BLISTERS; THE TOP WEB IS PRINTED WITH THE GRAPHICS, LOT NUMBER/EXPIRATION DATE AND BARCODE; THEN THE BLISTERS ARE CUT INTO INDIVIDUAL BLISTERS; THEN 10 UNITS ARE PLACE INSIDE OF SHELF CARTON. THE FIFTY (50) BLISTERS (10 SHELF CARTONS) ARE MANUALLY PACKED INTO EACH CASE CARTON. FOR COMPLAINT LOT, NEEDLE INSIDE OF THE BLISTER COMPLIED WITH NEEDLE DESCRIPTION OF BATCH AND SHELF CARTON. CONCLUSION(S): SINCE SAMPLES PROVIDED FOR EVALUATION CORRESPOND WITH INDICATED NEEDLE LENGTH DESCRIBE AT THE BOX, BD DID NOT CONFIRM CUSTOMER REPORTED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO NEEDLES SPINAL S/SU 22GA 5IN QUINCKE EXPERIENCED INCORRECT LABEL INFORMATION DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 405148 BATCH NO: 8123938 LENGTH OF NEEDLES IS NOT WHAT IS ON THE BOX.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA/510(K) #: PREAMENDMENT. 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 TWO NEEDLES SPINAL S/SU 22GA 5IN QUINCKE EXPERIENCED INCORRECT LABEL INFORMATION DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 405148, BATCH NO: 8123938. LENGTH OF NEEDLES IS NOT WHAT IS ON THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515414 NEEDLE SPINAL S/SU 22GA 5IN QUINCKE ANESTHESIA CONDUCTION NEEDLE BSP BD CARIBE LTD. 8123938 30382904051489

    Patients

    Seq Age Sex Outcome Treatment
    1 Other