MAUDE Adverse Event Report: PERIFIX

Model Number ES18271K

Device Problems Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/11/2016

Event Type  Injury  

Event Description

Anesthesia had difficulty removing catheter.Once it was removed, the tip could not be identified.It is believed that approx 1cm of the catheter was retained in the pt's back.

• Brand Name: PERIFIX
• Type of Device: PERIFIX
• MDR Report Key: 5384868
• MDR Text Key: 36883527
• Report Number: MW5059566
• Device Sequence Number: 1
• Product Code: CAZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: ES18271K
• Device Catalogue Number: 333192
• Device Lot Number: 0061429079
• Other Device ID Number: 08021-3331-92
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 80