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

Lot Number 23F18A0331

Device Problem Partial Blockage (1065)

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

Event Date 07/06/2018

Event Type  malfunction  

Event Description

Flex tip plus epidural catheterization kit.(b)(4).Lot 23f-18a0331.Needle blocked.

• Brand Name: FLEX TIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC. / TELEFLEX INC.
• MDR Report Key: 7689240
• MDR Text Key: 114077563
• Report Number: MW5078374
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 23F18A0331
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1