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

Catalog Number FR-05501-10

Device Problem Failure to Advance (2524)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evaluation.

Event Description

The customer alleges that it was impossible to introduce the catheter inside the needle; the catheter was stuck at the entrance of the needle.

Manufacturer Narrative

Qn#(b)(4).The customer returned one sealed kit from the same lot number for evaluation.The kit was opened and the epidural needle and epidural catheter were removed.The components were visually examined and no defects or anomalies were observed.A dimensional inspection was performed on the returned epidural needle and it was found to be within specification.Functional testing was also performed and there were no issues found.A device history record (dhr) review was performed on the epidural needle and epidural catheter with no relevant findings.The reported complaint of difficulty threading the epidural catheter through the needle could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.The returned epidural catheter could be threaded through the returned needle with no resistance met.The returned components passed a functional drag test, and the returned needle id and returned catheter od were found to be within specification.A dhr review was performed on the epidural needle and catheter with no evidence to suggest a manufacturing related cause.A potential root cause could not be determined based upon the information provided or without the actual complaint sample.

Event Description

The customer alleges that it was impossible to introduce the catheter inside the needle; the catheter was stuck at the entrance of the needle.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5391516
• MDR Text Key: 36849812
• Report Number: 3006425876-2016-00011
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: FR-05501-10
• Device Lot Number: 71F15J1926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1