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

Catalog Number EJ-05400-E

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2015

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 the device leaked.The catheter was removed and a new catheter was inserted without issue.No patient injury reported.

Manufacturer Narrative

(b)(4).The customer returned one epidural catheter, one snaplock adapter with clip, and one flat filter.A visual exam was performed on the filter and it was observed that the filter had tooling marks in the female luer.No other defects were observed.No issues were found with the snaplock adapter; however, the catheter appeared to be used as adhesive residue was present on the catheter body exterior.A small cut in the extrusion could be seen near offset coils approx 40cm from the distal end.No other defects were observed.Functional testing was performed and a leak could be seen immediately from the location of the offset coils in the catheter.No other leaks were detected.The test was repeated with the returned snaplock adapter and a lab inventory epidural catheter.No leaks were detected indicating that there are no functional problems with the returned snaplock adapter.A manual leak test was performed with the returned flat filter and no leaks were detected.A dhr review was performed on the epidural catheter and snaplock adapter with no relevant findings.The reported complaint of a leak from the connector was not confirmed based on the returned sample.The components were submitted to leak testing and neither the snaplock adapter, nor the flat filter other remarks: returned were found to leak.The returned catheter was found to leak as a result of a small cut in the extrusion located near offset coils.A dhr review was performed on the epidural catheter and snaplock adapter with no evidence to suggest a manufacturing related cause.Therefore, based on the damage observed and the time of discovery, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that the device leaked.The catheter was removed and a new catheter was inserted without issue.No patient injury reported.

• Brand Name: ARROW
• 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: 5219837
• MDR Text Key: 31234146
• Report Number: 3006425876-2015-00342
• 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: 11/02/2015

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: No Information
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: EJ-05400-E
• Device Lot Number: 71F14L1080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• 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