BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH 29G X 1/2 IN ATTACHED NEEDLE

    MDR report key: 10624226 · Received October 3, 2020

    Report

    Report Number
    1920898-2020-01351
    Event Type
    Malfunction
    Date Received
    October 3, 2020
    Date of Event
    September 14, 2020
    Report Date
    October 13, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED A PHOTO OF A SHIPPING CARTON WITH A LABEL FOR 1ML, 13MM, 29G BD SAFETYGLIDE INSULIN SYRINGES FROM CAT # 305930, LOT # 8002686 AND A PHOTO OF BLISTER PACKS OF 1/2CC, 13MM, 29G BD SAFETYGLIDE INSULIN SYRINGES FROM CAT # 305932. CUSTOMER STATES THAT THE PRODUCT WAS RECEIVED WITH INCORRECT LABELING. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED WHAT APPEARS TO BE A PRODUCT MIX. VISUAL INSPECTION OF THE PHOTOS SHOW THAT PRODUCT HAD INCORRECT LABELING. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED WHAT APPEARS TO BE A PRODUCT MIX. PROCESS SUMMARY: THE BLISTER PACK MACHINE PACKAGES THE SYRINGES INTO A SEQUENCE OF INDIVIDUALLY FORMED POCKETS IN THE BOTTOM WEB THAT IS HEAT-SEALED WITH THE TOP WEB AND THEN CUT INTO INDIVIDUAL BLISTERS. ROLLER BARS MAINTAIN ALIGNMENT OF THE TOP WEB AND CARRIER CHAIN CLAMPS MAINTAIN THE BOTTOM WEB, SO BOTH ARE ALIGNED TOGETHER TO CREATE A GOOD QUALITY SEAL ON THE BLISTER WHILE ENSURING EACH BLISTER PACKAGE HAS A COMPLETE LABELING LEGEND FOR PRODUCT IDENTIFICATION. THERE WAS A SITUATION ANALYSIS FORM ((B)(4)) COMPLETED ON 12 JUN 2018 FOR SAME INCIDENT FROM SAME BATCH: 305930. DETAILED INVESTIGATION AND ROOT-CAUSE ARE RECORDED IN (B)(4) REPORT. PLEASE DO REFER TO THE ((B)(4)) WITH THE COMPLAINT. ROOT CAUSE OF THE PROBLEM (IF KNOWN): 1) NON-SPECIFIC PROCEDURAL DIRECTIONS ON WHAT IS TO BE VERIFIED BY LABEL PRINT OPERATORS PRIOR TO PRINTING (HMFG-14, CONTROL OF LABELS). 2) NON-ADHERENCE TO A STANDARD ¿ DHR REVIEW CONDUCTED ON 26FEB2018 FAILED TO VERIFY THE CORRECT MATERIAL NUMBER DURING THIS REVIEW, AS OUTLINED IN HQA-20, MAINTENANCE OF DEVICE HISTORY RECORDS. 3) STORAGE OF RAW LABEL MATERIAL APPEARS TO NOT BE SUFFICIENT IN SEGREGATION OF MATERIALS SUCH. CORRECTIVE ACTION: A CAPA WAS OPENED FOR THIS COMPLAINT, CAPA-#472475. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29G X 1/2 IN ATTACHED NEEDLE HAD INCORRECT LABELING. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305930 BATCH NO. UNKNOWN (REPORTED FROM PHOTO: 8002686 - BELONGS TO P/N 305932). IT WAS REPORTED THAT THE PRODUCT WAS RECEIVED WITH INCORRECT LABELING. EVENT DESCRIPTION PER EMAIL STATES: WE OPENED A NEW BOX OF 1ML 29 G X 1/2" SYRINGES, REF # 305930, AND DISCOVERED THE INCORRECT SIZE INSIDE. THE BOX ACTUALLY CONTAINED REF# 305932, WHICH ARE 1/2 ML. THIS WAS CAUGHT BEFORE IT REACHED PATIENT, BUT COULD'VE LED TO INCORRECT DOSING. POTENTIAL DELAY OF THERAPY WHILE RE-ORDERING CORRECT PRODUCT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29G X 1/2 IN ATTACHED NEEDLE HAD INCORRECT LABELING. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305930 BATCH NO. UNKNOWN (REPORTED FROM PHOTO: 8002686 - BELONGS TO P/N 305932). IT WAS REPORTED THAT THE PRODUCT WAS RECEIVED WITH INCORRECT LABELING. EVENT DESCRIPTION PER EMAIL STATES: WE OPENED A NEW BOX OF 1ML 29 G X 1/2" SYRINGES, REF # 305930, AND DISCOVERED THE INCORRECT SIZE INSIDE. THE BOX ACTUALLY CONTAINED REF# 305932, WHICH ARE 1/2 ML. THIS WAS CAUGHT BEFORE IT REACHED PATIENT, BUT COULD'VE LED TO INCORRECT DOSING. POTENTIAL DELAY OF THERAPY WHILE RE-ORDERING CORRECT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088676 1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH 29G X 1/2 IN ATTACHED NEEDLE SYRINGE, ANTISTICK MEG BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other