BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC DRESSING CHANGE TRAY

    MDR report key: 12167414 · Received July 14, 2021

    Report

    Report Number
    1417592-2021-00118
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 19, 2021
    Report Date
    July 27, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL DOCUMENTATION CHANGED/ADDITIONAL INFORMATION ADDED. D9 DEVICE AVAILABLE FOR EVALUATION -N/A. G6 TYPE OF REPORT - FOLLOW-UP. H2 IF FOLLOW-UP WHAT TYPE? ADDITIONAL INFORMATION. H3 DEVICE EVALUATED BY MANUFACTURER - N/A. H6 TYPE OF INVESTIGATION- 3331. H5 INVESTIGATION CONCLUSION - ZCD00005/DEFECT CONFIRMED: UNKNOWN RESPONSIBLE PARTY. H10 INVESTIGATION REPORT READS AS FOLLOWS: 07/22/2021 14:18:35 CST (NCOAN). "EVALUATION OF THE PROVIDED PHOTOGRAPH CONFIRMED THE CUSTOMER'S REPORT. THIS COMPLAINT AND PHOTOGRAPH WERE FORWARDED TO THE VENDOR TO NOTIFY THEM OF THE ISSUE. HOWEVER, A RESPONSE FROM THE VENDOR HAS NOT BEEN RECEIVED AT THIS TIME. SHOULD A RESPONSE BE RECEIVED IN THE FUTURE, IT WILL BE ADDED TO THE COMPLAINT FILE. A REVIEW OF PRODUCTION RECORDS FOR EBSI1220 LOT NO. 2021032690 DID NOT FIND ANY NON-CONFORMANCES NOTED BY PRODUCTION OR QUALITY CONTROL PERSONNEL DURING FIRST ARTICLE, IN PROCESS, OR CASE PACKAGING INSPECTIONS. THE STERILIZATION RECORDS FOR EBSI1220 LOT NO. 2021032690 WERE ALSO REVIEWED AND FOUND THE PARAMETERS MET ALL PROCESS SPECIFICATIONS. CENTURION'S COMPLAINT HISTORY INDICATES NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR COMPONENT CODE 59195 SINCE IT WAS FIRST USED IN KIT ASSEMBLY IN 2017. THEREFORE, THIS INCIDENT APPEARS TO BE ISOLATED. BASED ON THIS INFORMATION, A ROOT CAUSE CANNOT BE POSITIVELY IDENTIFIED AT THIS TIME."

    Additional Manufacturer Narrative · 0

    EMAIL RECEIVED BY (B)(4), QUALITY ENGINEER, MEDLINE INDUSTRIES, INC., WHO RECEIVED ADDITIONAL INFORMATION FROM (B)(6), (B)(6) HEALTH SYSTEMS, PROVIDING ADDITIONAL INFORMATION IN REGARDS TO THIS REPORTED INCIDENT. REPORTER STATES, INCIDENT IS REPORTED AS OCCURRING ON (B)(6) 2021. REPORTER STATES, PATIENT IS A 75 YEAR-OLD, 277-POUND, WHITE, FEMALE. REPORTER STATES, PATIENT HAS A HISTORY OF ALLERGIES TO CIPROFLOXACIN (SKIN PEELS) AND PERCOCET (UNKNOWN REACTION). IT IS REPORTED THAT PATIENT "DOES USE MEDICATIONS THAT AFFECTS THE IMMUNE SYSTEM OR CAUSE SKIN REACTIONS." NO REPORTED REACTIONS WITH OTHER DRESSINGS OR TAPES. REPORTER STATES, SKIN PREPS WERE USED PRIOR TO APPLICATION OF THE 3M PRODUCT AND CHLORHEXIDINE GLUCONATE, AFTER ALCOHOL. REPORTER STATES, THREE PRIOR APPLICATIONS OCCURRED AFTER WHICH THE INCIDENT OCCURRED. IT WAS REPORTED, THERE WAS NO LEAKING NOTED. IN ADDITION, THE PLACEMENT OF A NEW 3M PRODUCT DID NOT OVERLAP THE PLACEMENT OF THE OLD ONE. REPORTER STATES, MEDICAL TREATMENT WAS NECESSARY TO TREATMENT MINOR INJURY DESCRIBED AS "MACERATION" AND "WHITE RAISED CLUSTERS." IT IS REPORTED THAT THE DRESSING WAS IN PLACE FOR TWO-DAYS BEFORE THE REACTION STARTED. IT IS UNKNOWN HOW LONG OR IF THE REACTION HAS RESOLVED. REPORTER STATES, "(B)(6) LINE WAS REMOVED AND NEEDED TO BE REPLACED." NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SUPPLEMENTAL MDR FILED ON 7/27/2021 WITH THE FDA TO REFLECT ADDITIONAL INFORMATION RECEIVED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, PATIENT OR PATIENTS DEVELOPED A CONDITION NOT YET DETERMINED BY PENDING BLOOD CULTURE. FACILITY SUSPECTS IT MAY BE DERMATOSIS VS A FUNGAL GROWTH.

    Description of Event or Problem · 0

    IT WAS REPORTED, PATIENT OR PATIENTS DEVELOPED A CONDITION NOT YET DETERMINED BY PENDING BLOOD CULTURE. FACILITY SUSPECTS IT MAY BE DERMATOSIS VS A FUNGAL GROWTH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED; PATIENT OR PATIENTS DEVELOPED A CONDITION NOT YET DETERMINED BY PENDING BLOOD CULTURE. FACILITY REPORTS AND "SUSPECTS IT MAY BE DERMATOSIS VS A FUNGAL GROWTH." DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED INCIDENT. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. SAMPLES ARE NOT AVAILABLE FOR RETURN AND EVALUATION. DUE TO THE REPORTED NATURE OF THE INCIDENT AND IN AN ABUNDANCE OF CAUTION, A MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, PATIENT OR PATIENTS DEVELOPED A CONDITION NOT YET DETERMINED BY PENDING BLOOD CULTURE. FACILITY SUSPECTS IT MAY BE DERMATOSIS VS A FUNGAL GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067561 PICC DRESSING CHANGE TRAY OXQ MEDLINE INDUSTRIES INC. 2021032690

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention