MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC

Catalog Number	75-038
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
While inserting picc line, the catheter became crimped when attempting to remove wire stylet.Surgeon had to come and remove catheter surgically.

• Brand Name: BIOFLO PICC
• Common Device Name: BIOFLO PICC
• Manufacturer (Section D): ANGIODYNAMICS; marlborough MA 01752
• MDR Report Key: 6435768
• Report Number: MW5068658
• Device Sequence Number: 10897910
• Product Code: LJS
• UDI-Device Identifier: H965750380
• UDI-Public: H965750380
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 75-038
• Device Lot Number: 5154953
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR