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

Catalog Number MED UNK

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 08/05/2014

Event Type  malfunction  

Event Description

The complaint was received via medwatch from the fda.The complaint alleges that while removing an epidural catheter; a portion of the catheter sheared off in the epidural space.The complaint alleges that a medical intervention was required but there is no report of patient injury or harm.

Manufacturer Narrative

(b)(4).Visual, functional and dimensional inspection could not be performed as no sample was returned by the customer for investigation.A device history record review could not be performed as the product number or lot number was not provided by the customer for investigation.A corrective action is not required as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed because no sample was returned for analysis.The device history records could not be reviewed because the product number and the lot number were not provided.Therefore, the potential cause of epidural catheter separation could not be determined based upon the information provided and without a sample.Note: the medwatch did not provide information allowing for a follow-up with the customer.There is no catalog number, no lot number, no user facility identifier, and no report of the patient's condition or intervention that was required.If the device sample is returned to the manufacturer for evaluation, this complaint will be updated.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4346779
• MDR Text Key: 20065254
• Report Number: 1036844-2014-00464
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MED UNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention