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

Catalog Number AK-05503

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

The customer alleges that on removal of the epidural catheter the coil separated from the catheter cover.It was left in the patient to identify issues.The device was removed from the patient later without incident.A ct scan identified that the catheter was out of the epidural space and in tissue.A hemostat was used to assist in removing the catheter.Removal was successful and without complications.

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.Although a segment of the device separated in the patient and was removed via hemostat; there was no residual injury or consequence to the patient.

• Brand Name: ARROW EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: margie burton rn ; 3015 carrington mill blvd.; morrisville, NC 27506 ; 9194334965
• MDR Report Key: 4373796
• MDR Text Key: 5262658
• Report Number: 1036844-2014-00498
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: AK-05503
• Device Lot Number: 23F14H1105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR