MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROW EPIDURAL CATHETERIZATION KIT

Model Number SJ-05501-0

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/04/2016

Event Type  malfunction  

Event Description

Patient had epidural placed for labor.After delivery, the rn attempted to remove the epidural catheter and met resistance.She stopped and notified md.He came and removed the catheter, but the tip was not intact and approximately 7" of the outer layer of the catheter broke off in the patient's back.Md consulted with neuro-surgery and obtained x-ray.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Type of Device: ARROW EPIDURAL CATHETERIZATION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL; reading PA 19605
• MDR Report Key: 5801877
• MDR Text Key: 49830626
• Report Number: MW5063450
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: SJ-05501-0
• 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: 35 YR