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

Catalog Number JC-05400-B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The connector disconnected (after the patient touched it).A new catheter was inserted.

Manufacturer Narrative

(b)(4).The customer returned one snaplock adapter for investigation.A visual exam was performed and there were no issues observed.Functional testing was performed and no issues were found.A device history record (dhr) review was performed on the snaplock adapter and epidural catheter with no relevant findings.The reported complaint of a disconnection between the snaplock adapter and catheter could not be confirmed based upon the sample received.The returned snaplock adapter passed all functional exams performed including a spo test.A dhr review was performed on the epidural catheter and snaplock adapter with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned sample.

Event Description

The connector disconnected (after the patient touched it).A new catheter was inserted.

• 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: 5397128
• MDR Text Key: 37047692
• Report Number: 3006425876-2016-00009
• 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: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F15J0919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• 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