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 Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information not provided.Date of event was not provided.Lot number was not provided.Without a lot number, expiration date and manufacturer date could not be determined.The customer stated they started to use this dressing within the last few months.Dressing removal technique for the cases of dislodgement was unknown.The dislodgements may have been related to dressing removal technique.3m followed up with facility for product education.The product ifu notes the following removal technique: stabilize catheter during removal of the 3m¿tegaderm¿ chg i.V.Securement dressing.Remove documentation label and securement tape strip(s) from top of dressing.Using a low and slow removal technique, start removing the dressing from where the catheter or tubing exits the dressing toward the catheter insertion site.Avoid skin trauma by peeling the dressing back, rather than pulling it up from the skin.When the chg gel pad is exposed, grasp a corner of the gel pad and the transparent film dressing between thumb and finger.If needed, sterile alcohol swabs or wipes, or sterile solutions (i.E., sterile water or normal saline) may be applied between gel pad and skin to facilitate removal of the gel pad dressing.If needed, a medical adhesive solvent can be used to help remove the dressing border.Continue the low and slow removal method until the dressing is completely removed.End of report.
Event or Problem Description
A hospital reported four pediatric patients experienced dislodgement of their newly inserted tunneled central catheters.1660 3m¿ tegaderm¿ chg chlorhexidine gluconate i.V.Securement dressings were reportedly applied to the catheter sites.The tunneled central catheter cuffs were noted to be exposed when the dressings were removed.No individual patient information was available.At least two of the patients required reinsertion of their tunneled central catheters.

• 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: 8256951
• Report Number: 2110898-2019-00014
• Device Sequence Number: 19311696
• Product Code: FRO
• UDI-Device Identifier: 30707387583911
• UDI-Public: 30707387583911
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K080620
• 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): 01/17/2019

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: 1660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/17/2019
• 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: Required Intervention