MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I.V. SECUREMENT DRESSING; TEGADERM CHG DRESSING

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Irritation (2076)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date and manufacture date cannot be determined without a lot number.Reporter stated he was sending the product for analysis.The sample has not been received to date.The nurse reported the 3-4 patients experienced irritation and/or infection, requiring admission.3m has made multiple requests to obtain specific information on each patient case.No further information has been provided.The reporter stated aqua guard is sent for patients to use for central venous lines when bathing or showering.It is unclear if aqua guard potentially caused an issue with moisture and thus irritation and/or infection.A 3m clinical specialist visited the facility to provide product education.Analysis is pending upon receipt of product.End of report.
Event or Problem Description
A vascular access nurse specialist alleged 3-4 outpatient pediatric patients (ages and genders not specified) experienced irritation and/or infection related to the use of 3m¿ tegaderm¿ chg i.V.Securement dressing.The nurse reported all patients required admission.Specific patient treatment details were not provided.A biopsy was performed for one female patient where fungus mold and (b)(6) was allegedly growing around the dressing.The nurse informed this issue had been noted in the summer when patients are out in the heat and in and around water.The nurse reported aqua guard is sent for patients to use for central venous lines when bathing or showering.

• Brand Name: 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I.V. SECUREMENT DRESSING
• Common Device Name: TEGADERM CHG DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8781986
• Report Number: 2110898-2019-00087
• Device Sequence Number: 19492661
• Product Code: FRO
• UDI-Device Identifier: 30707387578313
• UDI-Public: 30707387578313
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1657
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AQUA GUARD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention