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	Cellulitis (1768)
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 a hospitalized oncology patient was receiving a chemotherapy infusion through an implanted port.The implanted port was accessed with a huber needle and was allegedly secured with a 1665 3m¿ tegaderm¿ chg chlorhexidine gluconate i.V.Port dressing.The nurse reported the huber needle became dislodged and the chemotherapy medication leaked onto the patient's skin.The patient experienced a skin injury that resembled cellulitis.The patient was treated with iv antibiotics.The implanted port catheter could not be used.The patient required an insertion of a picc line to resume therapy.

• 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: 8273683
• Report Number: 2110898-2019-00015
• Device Sequence Number: 158977
• 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