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

Catalog Number AK-05502

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch # (b)(4).Visual, functional and dimensional inspection could not be performed as no sample was returned for analysis.A lot number was not provided by the customer.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, (b)(4) rev.01, was reviewed as a part of this complaint investigation.The ifu provides catheter warnings and precautions and warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if the catheter begins to stretch excessively.Do not use acetone on catheter surface.Acetone can weaken the structure of polyurethane materials," and additional advisories.A corrective action is not required at this time as the potential cause of a separated catheter could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.Other remarks: note: the medwatch submitted by the user facility indicated on b-2 outcomes attributed to adverse event - other serious.Teleflex contacted the user facility (denise palmer - risk management specialist) to obtained information regarding "other serious".Ms palmer indicated that this item was checked in error and there was no adverse patient outcome from this event.

Event Description

The customer reports that a patient, post colectomy, was given an epidural for post-op pain control.The nurse entered the room and found the epidural tubing disconnected and lying on the floor.The epidural site was intact, but the wire was unattached from the tubing.There was no report of patient injury.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5298833
• MDR Text Key: 33547245
• Report Number: 1036844-2015-00570
• 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,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2015

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: Health Professional
• Device Catalogue Number: AK-05502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 76 YR