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

Catalog Number JC-05400-B

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/15/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device is reportedly unavailable for investigation.The manufacturer will continue to monitor and trend related events.

Event Description

During insertion of the catheter a backflow was seen into the syringe and a leakage in the piston.An epidural breach was reported and prolonged surgery.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).A device history record review was performed on the lor syringe with no relevant findings.A corrective action is not required at this time as a potential root 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 lor syringe with no evidence to suggest a manufacturing related cause.The potential cause of lor syringe leaking could not be determined based upon the information provided and without a sample.

Event Description

During insertion of the catheter, a backflow was seen into the syringe and a leakage in the piston.An epidural breach was reported and prolonged surgery.The patient's condition was reported as unknown.

• 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: 6067398
• MDR Text Key: 58770747
• Report Number: 3006425876-2016-00326
• 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: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• 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: JC-05400-B
• Device Lot Number: 71F15J0919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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