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

Catalog Number ASK-05400-BW1

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.

Event Description

It was reported that there were broken vials and the glass syringe stuck on locked position.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 9239687
• MDR Text Key: 175072186
• Report Number: 1036844-2019-00986
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: ASK-05400-BW1
• Device Lot Number: UNKNOWN
• 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: 11/21/2019
• 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