MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC. FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT; CATHETER, CONDUCTION, ANESTHETIC

Model Number MANUFACTURER NUMBER: AK05503

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2021

Event Type  malfunction  

Event Description

Epidural catheter breakage.Fda safety report id # (b)(4).

• Brand Name: FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC.
• MDR Report Key: 13087506
• MDR Text Key: 282896600
• Report Number: MW5106277
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2021

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 Model Number: MANUFACTURER NUMBER: AK05503
• Device Lot Number: 23F21J0079
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Patient Sequence Number: 1