MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW; TEGADERM¿ IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Extravasation (1842)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

Lot number was not provided.Without a lot number, expiration date and manufacture date could not be determined.End of report.

Event Description

A nurse reported a patient from the er had their implanted port accessed with a huber needle for a power injection of ct contrast dye during a diagnostic test.A biopatch was reportedly placed under the huber needle and a 1668 tegaderm¿ iv transparent film dressing with adhesive-free window was applied to the site.The nurse reported the huber needle migrated out of the implanted port but remained under the skin.The patient reportedly experienced an extravasation of ct contrast dye in the skin around the port site.The dressing remained fully intact.The port was de-accessed and the patient was treated with multiple subcutaneous injections of hyaluronidase.

• Brand Name: 3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW
• Type of Device: TEGADERM¿ IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 7679259
• MDR Text Key: 113738413
• Report Number: 2110898-2018-00075
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/11/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention