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 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(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 user felt a resistance and could not inject the medical agent through the inserted catheter.As a result, the catheter was replaced by a new one.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported medication would not go through the catheter.The customer returned one opened kit (reference attached files (b)(4)).Returned in the opened kit were one 3ml luer lock syringe, one flat filter, one snaplock adapter, and one epidural catheter.The returned components were visually examined with and without magnification.Visual examination of the returned syringe revealed the syringe appears typical with no observed defects or anomalies.Visual examination of the returned flat filter revealed the filter appears typical with no observed defects or anomalies.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Reddish biological material can be seen within the inner coils of the catheter from the distal tip to approximately 7.5cm from the distal tip (reference files (b)(4)).A manual flow test was performed using the returned components.The returned 3ml syringe was connected other remarks: to the returned flat filter, snaplock adapter, and catheter.The 3 ml syringe is contraindicated for use with the flat filter.However, since the 3 ml syringe was the only syringe returned, it is unknown what size syringe the end user used at the time of malfunction.The ifu recommends that the end user inject using a 20 ml syringe.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 flat filter and 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 either the returned flat filter or snaplock adapter.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded approximately 71cm from the proximal end of the returned catheter until an occlusion was found.The wire would not thread any further.The total measurement of the returned catheter was approximately 91cm (c05158).An attempt was made to thread the lab inventory wire from the distal end.The wire threaded approximately 15cm before and occlusion was found.However, with minor force, the wire was able to thread completely through the catheter.The catheter was once again connected to the other returned components.Using hand pressure, water was injected and flow was established out of the distal tip of the returned catheter.The contents that was found to be occluding the distal tip of the catheter was further examined and confirmed to be biological material.A corrective action is not required at this time as the condition of the sample received and the information provided indicates that operational context caused or contributed to this event.The reported complaint of catheter being occluded was confirmed based on the sample received.The returned epidural catheter was found to be completely occluded with biological material.Excessive biological material was found to be occluding the catheter from the distal tip to approximately 7.5cm from the distal tip.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based on the condition of the sample received and the information provided, operational context caused or contributed to this event.

Event Description

The user felt a resistance and could not inject the medical agent through the inserted catheter.As a result, the catheter was replaced by a new one.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 CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5775457
• MDR Text Key: 48964115
• Report Number: 3006425876-2016-00189
• 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: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: JH-05500-J
• Device Lot Number: 71F15H0197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2015
• 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