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	Irritation (1941); Pain (1994); Injury (2348)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Blisters can potentially occur if the product is applied with tension.The product ifu has a precaution statement which states mechanical skin trauma may result if dressing is applied with tension.End of report.
Event or Problem Description
A nurse reported that pus, a small blister and slight arm pain occurred with two 1657 3m¿ tegaderm¿ chg chlorhexidine gluconate i.V.Securement dressing changes for a patient who had open-heart surgery.The dressing was applied to protect a peripherally inserted central catheter (picc) (double-lumen) in the upper right arm.The picc line was in place in the arm for 1.5 months prior to the alleged symptoms.The small blister was near the picc line insertion site.With each dressing change, the skin was prepped with a chlorhexidine swab and allowed to dry before dressing application.The picc line was removed and a new peripheral access line was placed.The patient was reported to have no fever, no elevated white blood cell count or any sign of infection.The patient is reportedly doing well.

• 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: 9072187
• Report Number: 2110898-2019-00108
• Device Sequence Number: 2475438
• Product Code: FRO
• UDI-Device Identifier: 30707387578313
• UDI-Public: 30707387578313
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/16/2019

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: 08/19/2019
• Initial Report FDA Received Date: 09/16/2019
• 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: 27 YR