MAUDE Adverse Event Report: TELEFLEX ARROW EPIDURAL CATHETERIZATION KIT

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

Event Type  Injury  

Event Description

Epidural catheter separated from the adaptor.The securement clip was in use as well.Arrow epidural catheterization kit inserted (b)(6) 2016.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Type of Device: ARROW EPIDURAL CATHETERIZATION KIT
• Manufacturer (Section D): TELEFLEX; reading PA 19605
• MDR Report Key: 6128966
• MDR Text Key: 61049447
• Report Number: MW5066352
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 11/23/2016

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 33 YR