MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROW EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Model Number AK-05501

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2017

Event Type  Injury  

Event Description

Epidural catheter placed for labor snapped while physician was removing, leaving part of distal catheter tip in the patient's epidural space.Neurosurgical opinion was increased possibility of morbidity with attempted removal so piece was left in patient.

• Brand Name: ARROW EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL
• MDR Report Key: 6279051
• MDR Text Key: 65940787
• Report Number: MW5067469
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: AK-05501
• Device Lot Number: 23F16J0011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR