MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05560-JMH1

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

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 on (b)(6) 2019 that the anesthesiologists were unable to push medication through the catheter.After removing the catheter, they were still unable to push the medication through.A new catheter was used, and it worked well.The doctor does not have a lot number for the catheter, and it was requested via email to see if she still has the catheter for evaluation/investigation.The doctor stated that the incident happened recently and that there was no injury or complications to the patient.

Manufacturer Narrative

Qn#(b)(4).A device history record review could not be performed as no lot number was provided by the customer.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was provided by the customer.The potential cause of the catheter being blocked could not be determined based upon the information provided and without a sample.

Event Description

It was reported on 12/10/2019 that the anesthesiologists were unable to push medication through the catheter.After removing the catheter, they were still unable to push the medication through.A new catheter was used, and it worked well.The doctor does not have a lot number for the catheter, and it was requested via email to see if she still has the catheter for evaluation/investigation.The doctor stated that the incident happened recently and that there was no injury or complications to the patient.

• Brand Name: SPINAL ANES/EPIDURAL CATH KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9470999
• MDR Text Key: 184740008
• Report Number: 1036844-2019-01089
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-05560-JMH1
• Device Lot Number: 0000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1