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

Catalog Number ASK-05500-KM

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2019

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 the user found it difficult to insert a catheter into the epidural needle because of resistance.The kit was replaced with a new one.

Event Description

It was reported that the user found it difficult to insert a catheter into the epidural needle because of resistance.The kit was replaced with a new one.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.The customer reported the medical agent would not flow through the catheter.The customer returned one empty kit with a snaplock assembly and an epidural catheter.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears typical used as biological material can be seen in the inner coils.No other defects or anomalies were observed.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 8.4ml/min (c05180), which is within the specification of 1ml/min.No blockages were found.The reported complaint of the medical agent not flowing through the catheter could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter and snaplock assembly 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.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8713800
• MDR Text Key: 148538107
• Report Number: 3006425876-2019-00419
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: ASK-05500-KM
• Device Lot Number: 71F18L0458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1