MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION KIT

Catalog Number MP-17019-TKL

Device Problem Difficult to Flush (1251)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The catheter would not flush and a new catheter was inserted.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter would not flush.The customer returned one 3 ml luer lock syringe, one snaplock adapter, one epidural catheter, and lidstock.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed the snaplock adapter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Adhesive can be seen on the outer extrusion of returned catheter and biological material can be seen within the inner coils.After functional testing, microscopic examination revealed the returned catheter does not have opened ports at the distal end as compared to a lab inventory catheter (b)(4).A manual flow test was performed using the returned components.A 20 ml lab inventory syringe was connected to the returned snaplock adapter and other remarks: returned catheter.Using hand pressure, the water was injected.No flow could be established out of the distal tip of the catheter.The test was repeated using the returned snaplock adapter with a lab inventory epidural catheter.Flow could be established to the distal tip of the catheter, indicating that there are no flow issues with the returned snaplock adapter.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded completely through the catheter until it stopped at the closed tip distal end.Microscopic examination of the distal end of the returned catheter revealed there were no ports holes as compared to a similar lab inventory catheter.Nonconformance, (b)(4), have been initiated to further investigate this complaint issue.The reported complaint of the catheter not flushing was confirmed based on the sample received.The returned epidural catheter was found not to have open ports at the distal end.A device history record review was performed on the epidural catheter with no relevant findings.However, based on the information provided and the results of the investigation, the potential root cause of this complaint issue is manufacturing related.Nonconformance, (b)(4), has been initiated to further investigate this complaint issue.

Event Description

The catheter would not flush and a new catheter was inserted.The patient's condition was reported as fine.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6226777
• MDR Text Key: 64014650
• Report Number: 1036844-2017-00001
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: MP-17019-TKL
• Device Lot Number: 23F16K0617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1