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

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

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 snaplock adapter and epidural catheter with no relevant findings. A corrective action is not required at this time as a potential cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed on the snaplock adapter and epidural catheter with no evidence to suggest a manufacturing related cause. Therefore, the potential cause of the catheter disconnecting from the snaplock adapter could not be determined based upon the information provided and without a 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: 5644429
• MDR Text Key: 44893974
• Report Number: 3006425876-2016-00115
• 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

• 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

• Device Expiration Date: 07/31/2017
• Device Catalogue Number: JC-05400-E
• Device Lot Number: 71F15G1079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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

Patient Treatment Data

Date Received: 05/10/2016 Patient Sequence Number: 1