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.

Manufacturer Narrative

Qn# (b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed with a potentially relevant finding.A nonconformance was initiated only as a general nc to temporarily allow certain finished good part numbers to be packaged with additional gauze in order to better secure medication ampules in the inner tray.Complaint verification testing could not be performed as no sample was returned for analysis.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed with a potentially relevant finding.Based on the information provided, the potential root cause of this issue is design related.A capa was initiated to further investigate this complaint issue.

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
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Catalogue Number: ASK-05400-BW1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1