MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA X 35; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05500-HC

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

The report states: we had 2 incidents with the ask-05500-hc flex tip plus catheterization kit, the catheter has a kink because the meds were not going through.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter is blocked.The customer returned one snaplock assembly, one epidural catheter, one luer-lock syringe, and lidstock.The returned components were received connected together (reference files (b)(4)).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock assembly appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Adhesive material can be seen on the outer extrusion of the catheter.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.7.The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester (c05176) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 10.4ml/min (c05180), which is within the specification of 1ml/min.No blockages were found.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of the catheter being blocked could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned components passed a functional flow test and met flow rate specifications.There were no functional issues found with the returned sample.

Event Description

The report states: we had 2 incidents with the ask-05500-hc flex tip plus catheterization kit, the catheter has a kink because the meds were not going through.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA X 35
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9279182
• MDR Text Key: 178329495
• Report Number: 1036844-2019-01017
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: ASK-05500-HC
• Device Lot Number: 13F19F0254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1