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	Erythema (1840); Fungal Infection (2419)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier & ethnicity: no information was provided.Product lot number was not provided.Expiration date and manufacture date cannot be determined without a lot number.The sample was not returned for evaluation and a lot number was not provided.The customer reported the dressing was exposed to moisture via diaphoresis and bathing/showering during wear.The reported fungal infection could have been promoted by the persistently high moisture levels under the dressing.The ifu for tegaderm chg dressings states "tegaderm chg gel pad is not designed to absorb large quantities of blood or fluid.".
Event or Problem Description
A nurse alleged that a male outpatient developed a fungal rash/infection on the left inner arm under a 3m¿ tegaderm¿ chg chlorhexidine gluconate i.V.Securement dressing.The dressing was used to protect a brachial picc line inserted for antibiotic administration.The nurse was unsure if skin preparation was conducted prior to dressing application.The rash/infection occurred within 24 hours of dressing application.The dressing was exposed to moisture via diaphoresis and bathing/showering during wear.The catheter was stabilized with stat-lock®.Diflucan, oral, was prescribed for the rash.The catheter remained in place.The patient reportedly had no pre-existing skin conditions or allergies to chlorhexidine gluconate or medical adhesives.

• 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: 9122425
• Report Number: 2110898-2019-00113
• Device Sequence Number: 19416326
• Product Code: FRO
• UDI-Device Identifier: 30707387578313
• UDI-Public: 30707387578313
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/26/2019

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: N/A
• Device Catalogue Number: 1657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 85