MAUDE Adverse Event Report: BARD BARD MY PICC KIT

Model Number CK000754

Device Problems Knotted (1340); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

While attempting an upper extremity picc line insertion to correct a looped malposition, a catheter exchange was required.The procedure aborted and the picc removed.The picc was knotted.

• Brand Name: BARD MY PICC KIT
• Type of Device: PICC
• Manufacturer (Section D): BARD ; franklin lakes NJ 07417
• MDR Report Key: 7181611
• MDR Text Key: 97080922
• Report Number: MW5074514
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: CK000754
• Device Catalogue Number: CK000754
• Device Lot Number: 17HB5026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR