MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION CATHETER

Catalog Number JC-05400-E

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the piston of the lor syringe broke in two pieces during aspiration of saline solution.

Manufacturer Narrative

(b)(4).This report 3006425876-2019-01098 is being retracted because the customer changed the number of devices in the complaint.Report #3006425876-2019-01098 is retracted.

Event Description

It was reported that the piston of the lor syringe broke in two pieces during aspiration of saline solution.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9526807
• MDR Text Key: 179444722
• Report Number: 3006425876-2019-01098
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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
• Device Expiration Date: 06/06/2021
• Device Catalogue Number: JC-05400-E
• Device Lot Number: 71F19F0330
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1