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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was not provided.Lot number was not provided.Without a lot number, expiration date and manufacturer date could not be determined.End of report.
Event or Problem Description
A nurse reported hospitalized oncology patients were receiving chemotherapy infusions through an implanted port.The implanted ports were accessed with a huber needle and were allegedly secured with a 1665 3m¿ tegaderm¿ chg chlorhexidine gluconate i.V.Port dressing.The nurse reported six patients experienced huber needle dislodgements in the past year.The patients required reinsertion of their huber needles.The nurse reported no other patient consequence/injury was associated with these dislodgements.

• 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: 8273698
• Report Number: 2110898-2019-00016
• Device Sequence Number: 1448537
• Product Code: FRO
• UDI-Device Identifier: 30707387770366
• UDI-Public: 30707387770366
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/24/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BARD SAFE SET HUBER NEEDLE LH-0032
• Outcome Attributed to Adverse Event: Required Intervention