BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PEN NEEDLE STERILE SINGLE USE

    MDR report key: 7465489 · Received April 26, 2018

    Report

    Report Number
    1920898-2018-00261
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 3, 2018
    Report Date
    April 27, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382904736989
    PMA / PMN Number
    K110105
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW FOR CATALOG# 47364902, BATCH# 7152647 (23G ETW X 7MM PEN NEEDLE EU). THIS BATCH WAS MANUFACTURED BETWEEN 28AUG2017 TO 11SEP2017. THERE WERE ZERO NOTIFICATIONS FOR ANY DEFECTS NOTED DURING MANUFACTURING OF THIS BATCH. A DEVICE HISTORY RECORD REVIEW FOR CATALOG# 47364902, BATCH# 7152644 (23G ETW X 7MM PEN NEEDLE EU). THIS BATCH WAS MANUFACTURED BETWEEN 02AUG2017 TO 11AUG2017. THERE WERE ZERO NOTIFICATIONS FOR ANY DEFECTS NOTED DURING MANUFACTURING OF THIS BATCH. A DEVICE HISTORY RECORD REVIEW FOR CATALOG# 47364902, BATCH# 7152645 (23G ETW X 7MM PEN NEEDLE EU). THIS BATCH WAS MANUFACTURED BETWEEN 11AUG2017 THRU 18AUG2017. THERE WERE ZERO NOTIFICATIONS FOR ANY DEFECTS NOTED DURING MANUFACTURING OF THIS BATCH. ON 11APR2018, THE HOLDREGE MANUFACTURING PLANT RECEIVED THE FOLLOWING COMPLAINT SAMPLES: THREE (3) PEN NEEDLES FROM BATCH# 7152647. DURING 100% INSPECTION, THREE (3) CRITICAL DEFECTS WERE IDENTIFIED: MISSING, DAMAGED OR DEFECTIVE LABEL AFFECTING STERILITY (VIA VISUAL MEANS; I.E., PUNCTURES, SLITS, TEARS IN THE TOP SEAL). THREE (3) PEN NEEDLES FROM BATCH# 7152644. DEFECT(S) REPORTED: DURING 100% INSPECTION, THREE (3) CRITICAL DEFECTS WERE IDENTIFIED: THREE (3) NEEDLES FOUND WITH DAMAGE TO NEEDLE COVER AFFECTING STERILITY (INCOMPLETE SEAL). THREE (3) PEN NEEDLES FROM BATCH# 7152645. DEFECT(S) REPORTED: DURING 100% INSPECTION, THREE (3) CRITICAL DEFECTS WERE IDENTIFIED: MISSING, DAMAGED OR DEFECTIVE LABEL AFFECTING STERILITY (VIA VISUAL MEANS; I.E., PUNCTURES, SLITS, TEARS IN THE TOP SEAL), QUANTITY=2 AND MISSING, DAMAGED, OR DEFECTIVE COVER AFFECTING STERILITY (VIA VISUAL MEANS; I.E., HOLES, CRACKS), QUANTITY=1. OF THE SAMPLES RECEIVED FOR BATCH# 7152644, TWO (2) WERE NOTED TO HAVE DAMAGE ALONG THE BOTTOM OF THE COVER, AS WELL AS THE RIM IMPACTING SEALING COMPLETION. IN BOTH INSTANCES, IT WAS NOTED THAT A PROPER AND INTACT SEAL ALONG THE COVER RIM WAS NOT COMPLETED. THIS IS NOT ATTRIBUTABLE TO ANY DAMAGE TO THE LABEL; HOWEVER, THIS IS LIKELY LINKED TO THE DAMAGE NOTED ON THE BOTTOM OF THE COVERS. ADDITIONALLY, ONE (1) SAMPLE FROM BATCH# 7152644 AND ONE (1) SAMPLE FROM BATCH# 7152645 WERE NOTED TO HAVE DAMAGE TO THE RIM OF THE NEEDLE COVER, RESULTING IN AN INCOMPLETE SEAL OF THE TEAR DROP LABEL. THIS TYPE OF DAMAGE IS CONSISTENT WITH PREVIOUSLY IDENTIFIED DAMAGE TO COVERS AT STATION 35 ON THE PRODUCTION LINE. AT STATION 35 THE COVERS ARE FULLY SEATED AND LEVELED IN THE NESTING PLATFORM WITH THE SEATING WHEEL. IF THE COVER IS ORIENTED IN THE PLATFORM AT AN ANGLE, IT IS POSSIBLE THE SEATING 3 WHEEL COULD DAMAGE THE COVER DURING THE LEVELING PROCESS. THE DAMAGED COVERS COULD STILL BE PROPERLY SEATED IN THE NESTING PLATFORM AND THUS WOULD COMPLETE THE ASSEMBLY PROCESS. AS PART OF BD¿S CULTURE OF CONTINUOUS IMPROVEMENT, THIS STATION WAS EQUIPPED WITH A SENSOR TO DETECT WHEN A COVER IS NOT SEATED PROPERLY (INSTALLATION COMPLETE (B)(6) 2017). WHEN A PART IS NOTED TO NOT BE SEATED CORRECTLY, THE PRODUCTION LINE STOPS UNTIL THE PART IS CLEARED AND THE LINE RESUMED BY AN OPERATOR. ADDITIONALLY, UPON REQUEST OF THE CUSTOMER, A CHALLENGE PART WAS MANUFACTURED AND IS UTILIZED TO VERIFY THAT THE SENSOR IS FUNCTIONING AS EXPECTED. THIS CHALLENGE BEGAN ON 18 AUG 2017 AND IS RUN AT THE BEGINNING OF EACH SHIFT. DAMAGED/DEFECTIVE LABEL AFFECTING STERILITY: OF THE SAMPLES RECEIVED, TWO (2) SAMPLES FROM BATCH# 7152645 WERE NOTED TO HAVE OPEN SEALS WITHOUT OTHER DAMAGE BEING NOTED TO THE NEEDLE COVER: TWO (2) SAMPLES FROM BATCH# 7152647 WERE NOTED TO HAVE A TORN TEAR DROP LABEL, AT OR NEAR THE RIM OF THE NEEDLE COVER. DAMAGE NOTED TO THE EXTERIOR OF THE COVER AND TO THE TEAR DROP LABEL, AS NOTED IN THE SAMPLE PHOTOS, WAS DETERMINED TO BE ATTRIBUTABLE TO A PREVIOUSLY UNIDENTIFIED STATION. AT STATION 52, A PAPER SUPPORT LEDGE IS UTILIZED TO SUPPORT THE FLOW OF LABEL MATERIAL. AN UNEVENNESS BETWEEN THIS SUPPORT AND THE ADJOINING PLATE WAS FOUND TO BE A CONTRIBUTING FACTOR TO DAMAGE FOUND ALONG THE RIM AND/OR SIDE OF THE COVERS. DAMAGE TO THE TEAR DROP LABEL WAS ALSO NOTED WHILE OBSERVING THE PRODUCTION LINE RUNNING DURING EVALUATION IN OCTOBER 2017. ADJUSTMENT TO THE THIS LOCATION ON THE MANUFACTURING LINE WAS COMPLETED AS OF 31 OCT 2017 TO HELP ELIMINATE THIS STATION FROM CAUSING FURTHER DAMAGE DURING PRODUCTION. ONE (1) SAMPLE FROM BATCH# 7152647 WAS NOTED TO HAVE A PUSHED-IN TEAR DROP LABEL, EXTENDING THROUGH THE MIDDLE AND PRINTED AREAS OF THE TEAR DROP LABEL: THIS TYPE OF DAMAGE WAS NOTED TO THE TEAR DROP LABEL, SUGGESTIVE OF BEING CAUSED DURING TRANSPORTATION OF THIS BULK PRODUCT. AS THE INDIVIDUAL PARTS ARE PLACED INTO THE DOUBLE BAGS, PARTS FREELY MOVE AGAINST ONE ANOTHER. THIS PRESENTS THE OPPORTUNITY THAT IF THE CASES UNDERGO UNDUE ¿ROUGH¿ HANDLING, INCLUDING BEING CRUSHED AND/OR TOSSED AROUND CARELESSLY, DOUBLE STACKING OF CASES, FOR EXAMPLE, THE PARTS CAN STRIKE AGAINST ONE ANOTHER WITH ENOUGH FORCE TO CAUSE SUCH DEFECT TO OCCUR. GENERALLY, YOU WOULD ANTICIPATE SEEING A LOW INCIDENT OF THIS FOR A GIVEN CASE/LOT. DURING PRODUCTION OF A STANDARD EIGHT (8) PALLET BATCH, THE FOLLOWING INSPECTIONS ARE PERFORMED AT THE ASSOCIATED SAMPLING LEVEL. THESE TESTS ARE PERFORMED AT THE START OF THE SHIFT AND THEN EVERY TWO (2) HOURS THEREAFTER.

    Additional Manufacturer Narrative · 1

    THREE POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 7152645; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2017-06-01. MEDICAL DEVICE LOT #: 7152644; MEDICAL DEVICE EXPIRATION DATE: 2022-06-30;  DEVICE MANUFACTURE DATE: 2017-06-01. MEDICAL DEVICE LOT #: 7152647; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2017-06-01. 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 THE DROP LABEL WAS FOUND DAMAGED "PUNCTURED, SLIT, TORE" AFFECTING STERILITY ON A BD¿ PEN NEEDLE STERILE SINGLE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307969 BD¿ PEN NEEDLE STERILE SINGLE USE INSULIN PEN NEEDLE FMI BD MEDICAL - DIABETES CARE SEE SECTION H.10. 00382904736989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other