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

Catalog Number AK-05502

Device Problems Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2015

Event Type  malfunction  

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 was performed on the epidural catheter with no relevant findings.The ifu for this kit was reviewed.The ifu 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 catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position." a corrective action is not required at this time 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 as no sample was returned for analysis.

Event Description

The customer alleges that there was resistance in removing the epidural catheter.No patient injury reported.

Manufacturer Narrative

(b)(4).The customer returned one epidural catheter, one snaplock adapter, and one 3ml injection syringe for investigation.A visual examination was performed on the snaplock and no defects were observed.The epidural catheter appeared to be used as adhesive residue was present on the catheter body exterior.The black marker indicating the distal tip was present.No pieces were missing at the distal end.The catheter length was measured and found to be approx.92.1 cm, which indicates the catheter was slightly stretched.The catheter was then lined up with a ruler to see if the marker bands were in line, and it was observed that the marker bands did not line up with a calibrated ruler beyond the 8cm marker band, thus indicating the catheter was stretched.A device history record (dhr) review was performed on the epidural catheter with no relevant findings.(con't) other remarks: the reported complaint of resistance during removal of the epidural catheter was confirmed based upon the sample received.Dimensional inspection of the returned catheter indicated that the catheter was stretched at least 0.6cm.No other defects or anomalies were observed.A dhr review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.The ifu for this product warns the user, "reposition patient to open the vertebral interspaces and reattempt removal if resistance is encountered or if catheter stretches excessively during removal." therefore, based upon the observed catheter stretching and the information provided, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that there was resistance in removing the epidural catheter.No patient injury reported.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5162588
• MDR Text Key: 28803197
• Report Number: 1036844-2015-00470
• 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: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F15D0087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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