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

Catalog Number JC-05400-B

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

(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 syringe of the set has no resistance because a leak is present, thus the identification of the epidural space is difficult.

Event Description

It was reported that the syringe of the set has no resistance because a leak is present, thus the identification of the epidural space is difficult.

Manufacturer Narrative

(b)(4). A device history record review was performed on the lor syringe with no relevant findings. A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample. Complaint verification testing could not be performed as no sample was provided for analysis. A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause. Therefore, the potential cause of the lor syringe leaking could not be determined based upon the information provided and without the sample.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8709016
• MDR Text Key: 148334836
• Report Number: 3006425876-2019-00400
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/21/2021
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F19C0265
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No