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

Catalog Number EJ-05400-E

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that a hole was found in the device prior to use.No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).The customer returned one epidural catheter piece.A visual exam was performed and it was observed that most of the catheter was returned as the proximal tip was undamaged and intact.At the other end, the catheter appears to have been cut.The coils remained tightly wound and did not extend beyond the extrusion.The catheter's inner coils were offset at approximately 18cm from the proximal end.Microscopic examination also revealed a small cut in the catheter extrusion and flattened coils.No other defects were observed.The returned catheter piece was measured and was found to be out of specification.Approximately 56.7cm of the catheter was missing.Functional testing was performed and a leak was found in the catheter.A dhr review was performed on the epidural catheter with no relevant findings.The reported complaint of a hole in the epidural catheter was confirmed based upon the sample received.The customer only returned approximately 31.8cm of the catheter.Functional and visual inspection of the returned epidural catheter piece confirmed to have two small cuts in the extrusion approximately 18cm from the proximal end.Other remarks: a dhr review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based upon the observed damage and the time of discovery, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that a hole was found in the device prior to use.No patient injury reported.

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5402706
• MDR Text Key: 37271789
• Report Number: 3006425876-2016-00026
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: EJ-05400-E
• Device Lot Number: 71F14K1561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2014
• 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