MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM CHLORHEXIDINE GLUCONATE IV PORT DRESSING; TEGADERM¿ CHG IV PORT DRESSING

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reinfusion (2403)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: information was not provided.Date of event was not provided.Report date, 8/15/2019, was used for the date of event.Lot number was not provided.Without a lot number, expiration date and manufacturer date could not be determined.Without a lot number, a batch record review could not be performed.3m will continue to monitor.End of report.
Event or Problem Description
A nurse manager reported a patient had a port needle secured with a 1665 3m¿ tegaderm¿ chg chlorhexidine gluconate i.V.Port dressing.The patient reportedly experienced a port needle dislodgement when the port was accessed in the er.Patient specific information was not provided.No further details were provided.

• Brand Name: 3M TEGADERM CHLORHEXIDINE GLUCONATE IV PORT DRESSING
• Common Device Name: TEGADERM¿ CHG IV PORT DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9009603
• Report Number: 2110898-2019-00103
• Device Sequence Number: 16738601
• Product Code: FRO
• UDI-Device Identifier: 30707387770366
• UDI-Public: 30707387770366
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123679
• 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): 09/12/2019

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: 1665
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/12/2019
• 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