BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB

    MDR report key: 9311300 · Received November 12, 2019

    Report

    Report Number
    1920898-2019-01276
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 25, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    30382903059455
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF BD 1ML, 13MM, 27G SAFETYGLIDE SYRINGES WITH BLISTER PACKS FROM LOT # 8325545, 9043583, AND 8325543. CUSTOMER STATES THAT WHEN THE SAFETY LOCK MECHANISM WAS ENGAGED, THE NEEDLE DISENGAGED FROM THE SYRINGE AND FLEW INTO THE PATIENT'S HAIR. THE PHOTOS WERE EXAMINED AND EXHIBITED THE HUB- NEEDLE-SAFETY MECHANISM ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9043583. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8325545. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8325543. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD (B)(4), "ON 20NOV2019, HOLDREGE RECEIVED A PHOTO OF ONE (1) SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB FROM MATERIAL NS305937. THREE (3) BATCH NUMBERS OF THE SAME CATALOG NUMBER WERE IDENTIFIED WAS REPORTED TO BE WERE THE NON-CONFORMING SYRINGE WAS FROM: 8325545, 9043583 OR 8325543. THE PHOTO CONTAINED A DISENGAGED NEEDLE/ADAPTER /HUB UNIT DETACHED FROM THE BARREL SITTING AT THE BOTTOM OF A SHARPS CONTAINER. WITHOUT THE PHYSICAL SAMPLE, NO ADDITIONAL INSPECTION OF THE COMPLAINT CAN BE PERFORMED. PROCESS: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE ASSEMBLES THE BARREL, STOPPER, PLUNGER AND NEEDLE ASSEMBLY COMPONENTS INTO A SYRINGE. THE MACHINE CONSISTS OF SEVERAL SYRINGE ASSEMBLY DIALS, INSPECTION AND TRANSFER DIALS. THIS TYPE OF DETACHMENT CAN OCCUR WHEN THE NEEDLE ASSEMBLY TRANSFER RAIL THAT FEEDS ONTO THE BARREL DIAL IS MISALIGNED CAUSING THE NEEDLE ASSEMBLY TO GET DAMAGED. MISALIGNMENT CAN OCCUR DUE TO COMPONENT JAMS. A MIS- ASSEMBLED SHIELD DETECTION SYSTEM (CAMERA) IS IN PLACE TO DETECT MISSING OR RAISED SHIELD AND WILL AUTOMATICALLY REJECT THE SYRINGE. THE CAMERA DETECTION IS CHALLENGED EACH PRODUCTION SHIFT. INVESTIGATION: NO QUALITY NOTIFICATIONS WERE MADE FOR THE 3 IDENTIFIED BATCHES REPORTED. IT IS NOT POSSIBLE TO IDENTIFY IF A SPECIFIC MAINTENANCE DISPATCH WAS COMPLETED AS SEVERAL WERE COMPLETED WITHIN THE THREE BATCHED IDENTIFIED. ROOT CAUSE: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS." H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    CORRECTION: CUSTOMER PROVIDED POSSIBLE LOT NUMBERS. THE FOLLOWING INFORMATION HAS BEEN UPDATED: ACTUAL LOT NUMBER IS UNKNOWN, HOWEVER THE CUSTOMER SUSPECTS: MEDICAL DEVICE LOT #: 8325543. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. DEVICE MANUFACTURE DATE: 2018-11-21. OR MEDICAL DEVICE LOT #: 9043583. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-02-12.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305945; BATCH NO.: UNKNOWN. IT WAS REPORTED THAT WHEN THE SAFETY LOCK MECHANISM WAS ENGAGED, THE NEEDLE DISENGAGED FROM THE SYRINGE AND FLEW INTO THE PATIENT'S HAIR. VERBATIM: MA ADMINISTERED A PPD AND USING THE STANDARD BD SAFETYGLIDE 1ML SYRINGE WITH 27G X 1/2. WHEN ENGAGING THE SAFETY LOCK MECHANISM, THE NEEDLE DISENGAGED FROM THE SYRINGE AND FLEW INTO THE PATIENT'S HAIR. NO INJURY REPORTED TO PATIENT OR MA. THREW THE PACKAGE AWAY IN THE TRASH AFTERWARDS AND WHEN SHE LOOKED IN THE TRASH SEVERAL MINUTES LATER, WE FOUND THE FOLLOWING LOT NUMBERS: 8325545H (EXP 11/30/23) 9043583A (EXP 2/29/24). - DATE/TIME OF OCCURRENCE: (B)(6) 2019 11:40:00 AM SUPPLIES ARE COUNTED AND REPLENISHED DAILY. HOWEVER, NORMALLY SEALED OR WRAPPED ITEMS ARE NOT OPENED TO CHECK FOR VALIDITY. TO DO SO, COULD COMPROMISE THE INTEGRITY OF PRODUCT. THIS COULD POSSIBLY BE A ONE-TIME- INCIDENT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305945, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT WHEN THE SAFETY LOCK MECHANISM WAS ENGAGED, THE NEEDLE DISENGAGED FROM THE SYRINGE AND FLEW INTO THE PATIENT'S HAIR. VERBATIM: MA ADMINISTERED A PPD AND USING THE STANDARD BD SAFETYGLIDE 1ML SYRINGE WITH 27G X 1/2. WHEN ENGAGING THE SAFETY LOCK MECHANISM, THE NEEDLE DISENGAGED FROM THE SYRINGE AND FLEW INTO THE PATIENT'S HAIR. NO INJURY REPORTED TO PATIENT OR MA. THREW THE PACKAGE AWAY IN THE TRASH AFTERWARDS AND WHEN SHE LOOKED IN THE TRASH SEVERAL MINUTES LATER, WE FOUND THE FOLLOWING LOT NUMBERS: 8325545H (EXP 11/30/23), 9043583A (EXP 2/29/24). DATE/TIME OF OCCURRENCE: (B)(6) 2019 11:40:00 AM. SUPPLIES ARE COUNTED AND REPLENISHED DAILY. HOWEVER, NORMALLY SEALED OR WRAPPED ITEMS ARE NOT OPENED TO CHECK FOR VALIDITY. TO DO SO, COULD COMPROMISE THE INTEGRITY OF PRODUCT. THIS COULD POSSIBLY BE A ONE-TIME-INCIDENT.

    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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305945 , BATCH NO.: UNKNOWN. IT WAS REPORTED THAT WHEN THE SAFETY LOCK MECHANISM WAS ENGAGED, THE NEEDLE DISENGAGED FROM THE SYRINGE AND FLEW INTO THE PATIENT'S HAIR. VERBATIM: MA ADMINISTERED A PPD AND USING THE STANDARD BD SAFETYGLIDE 1ML SYRINGE WITH 27G X 1/2. WHEN ENGAGING THE SAFETY LOCK MECHANISM, THE NEEDLE DISENGAGED FROM THE SYRINGE AND FLEW INTO THE PATIENT'S HAIR. NO INJURY REPORTED TO PATIENT OR MA. THREW THE PACKAGE AWAY IN THE TRASH AFTERWARDS AND WHEN SHE LOOKED IN THE TRASH SEVERAL MINUTES LATER, WE FOUND THE FOLLOWING LOT NUMBERS: 8325545H (EXP 11/30/23), 9043583A (EXP 2/29/24). DATE/TIME OF OCCURRENCE: (B)(6) 2019 11:40:00 AM. SUPPLIES ARE COUNTED AND REPLENISHED DAILY. HOWEVER, NORMALLY SEALED OR WRAPPED ITEMS ARE NOT OPENED TO CHECK FOR VALIDITY. TO DO SO, COULD COMPROMISE THE INTEGRITY OF PRODUCT. THIS COULD POSSIBLY BE A ONE-TIME-INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103268 SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB PISTON SYRINGE MEG BD MEDICAL - DIABETES CARE SEE H.10 30382903059455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other