MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM I.V. ADVANCED SECUREMENT DRESSING; TEGADERM¿ I.V. ADVANCED SECUREMENT DRESSING

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Venipuncture (2129)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was not specified.Complaint was created on (b)(6) 2018 was used as date of the event.Incorrect application technique may have contributed to this adverse event report.A cotton ball appeared to be placed under the adhesive of the 1680 tegaderm¿ iv advanced securement dressing which would inhibit the dressing from adhering to the catheter and skin for securement.This report was submitted to the fda because the infant required a reinsertion of a picc catheter.End of report.

Event Description

A hospital in (b)(6) reported a 1680 tegaderm¿ iv advanced securement dressing was applied to a infant's picc catheter site.The infant was reportedly "sweaty, had agitated legs and was in an incubator." the infant reportedly experienced a 5-10 cm "traction" (dislodgement) of the picc catheter.The infant required a new picc catheter insertion.The dressing reportedly remained intact.No additional information was available.

• Brand Name: 3M TEGADERM I.V. ADVANCED SECUREMENT DRESSING
• Type of Device: TEGADERM¿ I.V. ADVANCED SECUREMENT DRESSING
• 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 ; 275 5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 7850227
• MDR Text Key: 119339295
• Report Number: 2110898-2018-00085
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 1680
• Device Lot Number: 2019 07 JC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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