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

Catalog Number UR-05501-EXP

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2016

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

Insertion of the catheter was easy without any problems, but injection of the anesthesia was not possible.The catheter was removed and replaced.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 is blocked and medication will not go through.The customer returned one epidural catheter, one snaplock adapter, and lidstock.The components were received connected together (reference files (b)(4)).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen within the inner coils of the catheter.A flow test was performed on the returned snaplock adapter and returned catheter.The returned catheter was inserted from the proximal end into the returned snaplock adapter until it bottomed out and the snaplock adapter was closed.The components were confirmed to be secured by tugging gently.The snaplock adapter was connected to the lab leak other remarks: tester ((b)(4)) and the pressure was increased to 10 psi to establish flow.No flow could be established out of the distal tip of the returned catheter.The test was repeated using the returned snaplock adapter and a lab inventory 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 approximately 46.4cm 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 ((b)(4)).An attempt was made to thread the lab inventory wire from the distal end.The wire threaded approximately 43.5cm before and occlusion was found.The wire would not thread any further.Microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils at both measured places where the lab inventory wire would not thread any further and the catheter is completely occluded.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.Microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils at approximately 46.4cm from the proximal end and 43.5cm from the distal end.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

Insertion of the catheter was easy without any problems, but injection of the anesthesia was not possible.The catheter was removed and replaced.The patient's condition was reported as fine.

• Brand Name: EPIDURAL CATHETERIZATION SET
• 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: 6022797
• MDR Text Key: 57268812
• Report Number: 3006425876-2016-00308
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UR-05501-EXP
• Device Lot Number: 71F16F1971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention