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

(b)(4) the customer returned one epidural catheter, one epidural needle with stylet, and one flat filter.The returned components were visually examined and no defects were observed.A dimensional inspection was performed on the returned epidural needle and catheter and they were found to be within specification.Functional testing was also performed and no issues were 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 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 inner diameter and returned catheter outer diameter were found to be within specification.A dhr review was performed on the epidural needle and catheter with no relevant findings.

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: 5391501
• MDR Text Key: 36849335
• Report Number: 3006425876-2016-00010
• 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