• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

3M HEALTH CARE 3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW TEGADERM¿ IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Extravasation (1842)
Event Date 06/30/2018
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 an inpatient was receiving an iv tpn infusion via an implanted port. The port was accessed with a huber needle. A biopatch was placed under the huber needle and a 1668 tegaderm¿ iv transparent film dressing with adhesive-free window dressing 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 tpn fluid in the skin around the port site. The dressing remained fully intact. The port was de-accessed and was not able to be used immediately following the event. A peripheral iv catheter was inserted for patient access. The nurse reported pharmacy was consulted and no agent was required to treat the extravasation of tpn. The nurse reported no known skin injury occurred and he thought the port was able to be re-accessed later the same day after the swelling and oozing subsided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW
Type of DeviceTEGADERM¿ 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 Key7675571
MDR Text Key113620888
Report Number2110898-2018-00074
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number1668
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2018
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 Treatment Data
Date Received: 07/10/2018 Patient Sequence Number: 1
-
-