MAUDE Adverse Event Report: ARROW INT'L, INC. ARROW EPIDURAL CATHETER KIT

Model Number SJ-05501

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/11/2016

Event Type  malfunction  

Event Description

Epidural tip not intact upon removal.Discontinued epidural catheter, when removing catheter noticed tip was missing."retained foreign object.".

• Brand Name: ARROW EPIDURAL CATHETER KIT
• Type of Device: ARROW EPIDURAL CATHETER KIT
• Manufacturer (Section D): ARROW INT'L, INC.; morrisville NC
• MDR Report Key: 6165949
• MDR Text Key: 62233525
• Report Number: MW5066627
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: SJ-05501
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F16G0362
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR