MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CENTRAL LINE DRESSING KIT (09C )623; DRESSING CHANGE TRAY

Model Number	03-8909D
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results are pending, including investigation regarding whether the customer did approve the substitution.A follow-up report will be submitted.
Event or Problem Description
Customer believes that they did not previously approve a change in the dressing component in their custom kit from a medline product (svud73afqb) to a 3m tegaderm.While the customer is not saying definitively that the 3m tegaderm dressing substitution was the cause of the increase in clabsi, they believe it is likely a contributing factor for the increase in clasbi infections at the facility.The complaint did not identify any defects or deficiencies with the kit or components.
Additional Manufacturer Narrative
This supplemental report is being filed since investigation results are available following the submission of the initial mdr report.As part of the investigation into these events, a customer meeting was held on (b)(6), 2022, with multidisciplinary team members from (b)(6) health which included quality management, medical safety, and sales, along with team members from bayfront medical which included clinical, risk management, quality, and infection prevention.During the call, (b)(6) medical team clarified that they were not alleging deficiency with the tegaderm product, nor were they alleging that the tegaderm caused the infections.(b)(6) medical team also acknowledged that although they did see an increase in infections, there may be many possible causes.Because the possible causes of central line infections are multifactorial, the team was investigating all possible contributing factors, including (but not limited to) this substitution.(b)(6) health was notified of the events at (b)(6) medical on (b)(6), 2022; however, the customer has been utilizing the (b)(6) health custom kit with the substituted 3m tegaderm dressing since (b)(6) 2020, with the substitute component being implemented after (b)(6) health followed its established substitution process.A total of (b)(4) were produced for (b)(6) medical utilizing the 3m tegaderm dressing.(b)(6) health has not received any other complaints for the 3m tegaderm dressing for this issue from bayfront or any other customer.An investigation into the reported concern determined that (b)(4) health followed its established processes and procedures for the component substitution.This process includes obtaining and documenting customer approval as well as review by a product review committee (prc) to ensure that the substituted component meets the same operational specification as the original component.According to the cdc's catheter site regimen recommendation within the guidelines for the prevention of intravascular catheter-related infections, the use of either a "sterile gauze or sterile, transparent, semipermeable dressing" is recommended to cover the catheter site (cdc, 2015).The item number 1688ns (3m tegaderm iv transparent with adhesive and window) meets this recommendation.The substitution process allows customers to substitute alternate devices when a component is not available instead of omitting from a kit, thus ensuring the customer has necessary devices for their procedures.

• Brand Name: CENTRAL LINE DRESSING KIT (09C )623
• Common Device Name: DRESSING CHANGE TRAY
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13608113
• Report Number: 1423537-2022-00723
• Device Sequence Number: 20137612
• Product Code: OXQ
• UDI-Device Identifier: 10888439921847
• UDI-Public: 10888439921847
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 03-8909D
• Device Catalogue Number: 03-8909D
• Device Lot Number: 712474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 04/20/2022
• Date Device Manufactured: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 68 KG