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

Catalog Number EJ-05400-E

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

Soon after injecting medication into the flat filter the medication did not go through the filter because the filter was clogging.The catheter and the flat filter were replaced.There was no patient injury.

Manufacturer Narrative

(b)(4).A device history record review was performed on the filter with no relevant findings.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the filter with no evidence to suggest a manufacturing related cause.The potential cause of the filter being blocked could not be determined based upon the information provided and without a sample.

Event Description

Soon after injecting medication into the flat filter the medication did not go through the filter because the filter was clogging.The catheter and the flat filter were replaced.There was no patient injury.

Manufacturer Narrative

(b)(4).The customer reported the flat filter is clogged.The customer returned one flat filter (reference attached files (b)(4)).The returned filter was visually examined with and without magnification.Visual examination of the returned filter revealed the filter appears typical with no observed defects or anomalies.A manual flow test was performed using the returned filter.A 20ml lab inventory syringe was connected to the returned flat filter.Using hand pressure, the water was injected.Water could be seen immediately exiting the other end of the filter.No blockage were found.The reported complaint of the filter being clogged could not be confirmed based on the sample received.A device history record review was performed on the flat filter with no evidence to suggest a manufacturing related issue.The returned filter passed a functional flow test.There were no functional issues found with the returned sample.

Event Description

Soon after injecting medication into the flat filter the medication did not go through the filter because the filter was clogging.The catheter and the flat filter were replaced.There was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6794004
• MDR Text Key: 82684518
• Report Number: 3006425876-2017-00259
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: EJ-05400-E
• Device Lot Number: 71F16H1253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1