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

Catalog Number JH-05500-J

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

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

After placement of the catheter, the medical agent could not be injected through the inserted catheter so the catheter was replaced by a new one.After removal, the physician tried to flush the defect catheter with tap water but could not.The next day, the physician tried to flush the catheter again; the resistance in injecting water gradually faded away and water went through the catheter smoothly.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 medication could not be injected through the catheter.The customer returned one epidural catheter, one snaplock adapter, one flat filter, and one non-teleflex 5 ml luer slip syringe.The catheter, snaplock adapter, and non-teleflex syringe were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.A manual flow test was performed using the returned components.A 20 ml lab inventory syringe was connected to the returned flat filter, snaplock adapter, and catheter.Using hand pressure, the water was injected.A small flow of water could be seen exiting the distal end of the catheter, however, the filter was leaking along the seam.The filter was removed and a manual flow test was once again performed with just the returned snaplock other remarks: adapter and returned catheter with a 20 ml lab inventory syringe.Using hand pressure, the water was injected.Water could be seen immediately exiting the distal end of the catheter.No blockages were found.The ifu for this product, j-05500-101a; rev.11, was reviewed as a part of this complaint investigation.The ifu for this product indicates to only use the syringe that is provided with this kit.The customer returned a non-teleflex syringe that was received connected to the snaplock adapter and catheter.A corrective action is not required at this time as the complaint could not be confirmed.Medication could be injected through the returned catheter.However, the returned filter did leak along its seam.The leak appears to be the result of improper use and the incorrect syringe being used as the plastic is white along the seam as if high pressure was applied when injecting.Based on this and the condition of the sample received, operational context caused or contributed to this event.

Event Description

After placement of the catheter, the medical agent could not be injected through the inserted catheter so the catheter was replaced by a new one.After removal, the physician tried to flush the defect catheter with tap water but could not.The next day, the physician tried to flush the catheter again; the resistance in injecting water gradually faded away and water went through the catheter smoothly.The patient's condition was reported as fine.

• Brand Name: 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6087452
• MDR Text Key: 59464017
• Report Number: 1036844-2016-00552
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: JH-05500-J
• Device Lot Number: 71F15H0464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2015
• 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
• Patient Outcome(s): Required Intervention