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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Skin Irritation (2076)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample has not been received for analysis.The sample will be evaluated, when received.
Event or Problem Description
A facility in (b)(6) reported a (b)(6)-year-old female with a ij cvc line for antibiotic deliver developed skin lesions (erythema and pustules) with use of a 1657r 3m¿ tegaderm¿ chg chlorhexidine gluconate i.V.Securement dressing.The dressing was on for more than 7 days.Multiple dressings had been applied.Prior to dressing applications, chloroprep/chg and cavilon¿ no sting barrier film were used.The lesions presented under the chg gel pad.The patient had no prior history of skin conditions or sensitivity to adhesive.Tegaderm¿ chg was discontinued, catheter was removed, and a new line was placed.The skin reaction healed.
Additional Manufacturer Narrative
Tegaderm 1657r dressings from lots 334l9m, 334ccl and 334cw9 was received by 3m qa for analysis.Dressing samples were tested for gel adhesion to steel and chg content.All test results met acceptance criteria and no product quality issues were identified.3m will continue to monitor.End of report.

• 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: 9485012
• Report Number: 2110898-2019-00150
• Device Sequence Number: 2930135
• Product Code: FRO
• UDI-Device Identifier: 30707387578313
• UDI-Public: 30707387578313
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K080620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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 Expiration Date: 06/09/2021
• Device Model Number: N/A
• Device Catalogue Number: 1657R
• Device Lot Number: 334L9M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/29/2020
• 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: Required Intervention