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

Catalog Number JC-05400-B

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2018

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 there was a leak at the plunger level of the syringe.It was noticed at pre-test.

Event Description

It was reported that there was a leak at the plunger level of the syringe.It was noticed at pre-test.

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 a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the lor syringe with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the 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: 7964810
• MDR Text Key: 123684613
• Report Number: 3006425876-2018-00653
• 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: 09/26/2018

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: 05/22/2020
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F18E1853
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1