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

Catalog Number JC-05400-E

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported event: it was reported that the connector loosens time after time at the catheter end.The catheter was replaced.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and snaplock adapter with no relevant findings.The customer reported the catheter disconnected from the snaplock adapter.The customer returned one snaplock adapter, one flat filter, and a piece of an epidural catheter approximately 8.5cm (reference files (b)(4)).The components were received connected together and no snaplock clip was returned.The 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.Visual examination of the returned flat filter revealed that the flat filter appears typical with no observed defects or anomalies.A functional leak test was performed per mrq 000017 section 6.5 rev.5 using a lab inventory catheter and the returned snaplock adapter.The proximal end of the epidural catheter was inserted into the snaplock adapter until it bottomed out and the snaplock was closed.The components were confirmed to be secured by tugging gently on the catheter.The snaplock adapter was then connected to the lab leak other remarks: tester (c05176) and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.No leaks were detected.A second functional test was performed using the returned components per mrq 000017 section 6.7 rev.5 spontaneous partial opening.The catheter was confirmed to be secured in the snaplock adapter and then the components were left to sit for 72 hours in the closed position.After 72 hours, the snaplock adapter was examined and confirmed to remain in the closed position with the catheter secure.No functional issues were found with the snaplock adapter.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of a disconnect between the snaplock adapter and the epidural catheter could not be confirmed based upon the sample received.The returned components passed all functional testing including a spontaneous partial opening test.A device history record review was performed on the epidural catheter and snaplock adapter with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned sample.

Event Description

Reported event: it was reported that the connector loosens time after time at the catheter end.The catheter was 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: 5643030
• MDR Text Key: 44891406
• Report Number: 3006425876-2016-00106
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• 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: JC-05400-E
• Device Lot Number: 71F15G1079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2015
• 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