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

Catalog Number JC-05400-B

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the filter exploded during injection.The medication could not be injected.No clinical consequences.A new filter was used.The patient condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one opened kit containing one flat filter for investigation.A visual exam was performed and it was observed that the filter appeared to be used.The white inner filter appeared slightly discolored.The housing of the filter was typical.No cracks or signs of damage were observed.Functional testing was also performed and no leaks were detected.A device history record (dhr) review was performed on the flat filter with no relevant findings.Based on the investigation performed, the reported complaint that the filter exploded during injection could not be confirmed.The returned filter was received intact and passed a functional leak test.A dhr review was performed on the flat filter with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned flat filter.

Event Description

The customer alleges that the filter exploded during injection.The medication could not be injected.No clinical consequences.A new filter was used.The patient condition is reported as fine.

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5267980
• MDR Text Key: 32713637
• Report Number: 3006425876-2015-00371
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F15J0262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1