MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT; EPIDURAL CATHETER/ANESTHESIA CONDUCTION KIT

Model Number 19 GAUGE

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/16/2019

Event Type  Injury  

Event Description

When the rn was removing the epidural catheter, it was noted that the catheter tip was not intact.The patient was taken to the operating room for removal of the tip on (b)(6) 2018.

• Brand Name: FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: EPIDURAL CATHETER/ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.
• MDR Report Key: 8386026
• MDR Text Key: 137732300
• Report Number: MW5084571
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 19 GAUGE
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F18M0381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR