MAUDE Adverse Event Report: TIDI PRODUCTS, LLC VYGON; PICC (AND STABILIZER)

Model Number 5804.08

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

Product was not available for return to tidi for evaluation.Report is based on medwatch submitted by user facility, (b)(4).Customer admitted to applying the device too tightly causing bruising to patient.At this time there is no evidence that a manufacturing nonconformity contributed to the reported complaint.The instructions for use were reviewed and provided adequate instructions for effective use of the device.Manufacturer reference file number (b)(4).

Event Description

Customer reported that "dark discoloration noted on right lower leg after picc removal, under the stabilizer".

• Brand Name: VYGON
• Type of Device: PICC (AND STABILIZER)
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: jackie krieglstein ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 7456891
• MDR Text Key: 106388169
• Report Number: 2182318-2018-00001
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5804.08
• Device Lot Number: 28853245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2017
• 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): Other