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 No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

Specific date of occurrence was not provided.On (b)(6) 2018 was used for date of occurrence since the customer reported they switched to this dressing within the last couple of weeks.Lot number was not provided.Without a lot number, expiration date and manufacture date could not be determined.The customer reported no patient injury was associated with this adverse event.An mdr was sent for this report because the patient required reinsertion of a huber needle to prevent loss of therapy.

Event Description

A nurse reported an outpatient was receiving an iv chemotherapy infusion via an implanted port at home.The port was accessed with a huber needle and the chemotherapy was infusing via an iv pump.A 1668 3m¿ tegaderm¿ iv transparent film dressing with adhesive-free window was applied to the site.The patient returned the following day and the huber needle was partially dislodged from the port.The dressing was reportedly still intact.The port catheter was re-accessed with a new huber needle, redressed and the chemotherapy infusion was restarted.

• 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: 7655329
• MDR Text Key: 112909436
• Report Number: 2110898-2018-00065
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: N/A
• Device Catalogue Number: 1668NS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• 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
• Treatment: HUBER NEEDLE
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR