MAUDE Adverse Event Report: ARROW INTERNATIONAL EPIDURAL CATHETERIZATION KIT; EPIDURAL CATHETER SNAP LOCK DEVICE

Model Number SJ-05501

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

Female pt term pregnancy had labor epidural placed using arrow epidural catheterization kit and was noted at some time later that the snap-lock connection had loosened causing the catheter to leak.Per manager of unit, she spoke to the anesthesis provider who advised that leaking at the snap lock connection will occur if the device is not fully seated.Per manager, this event has occurred in two other instances since (b)(6) of this year, all epidurals inserted by different providers.No negative outcome for the patients.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: EPIDURAL CATHETER SNAP LOCK DEVICE
• Manufacturer (Section D): ARROW INTERNATIONAL; reading 19605
• MDR Report Key: 4466286
• MDR Text Key: 5320197
• Report Number: MW5040454
• 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: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: SJ-05501
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F14H1448
• Other Device ID Number: (01)00801902013699
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 117