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

Model Number IPN040153

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Intermittently, we have had some issues with passing the arrow catheters through the peripheral nerve block tray tuohy.The arrow catheters have been reported to me as being flimsier than previously.Seems to reach a weak point at 13-15 cm.We had an issue passing the catheter, changed then catheter (did not help) then we changed the tuohy (i pulled a separate sterile tuohy), and it was ok.I also just heard that about 1 week ago the catheter could not pass and would not pull out of the tuohy, so the entire needle and catheter was removed together.Just wanted to report that this has been occurring for some of the doctors.I will save the actual supplies if this occurs again, but i did get lot numbers out of the garbage.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.A review of design change history for part number kz-05400-030 was performed as a part of this investigation.No design changes have been made to this part in the past two years that would have led to this complaint.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 was performed on the epidural catheter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.

Event Description

Intermittently, we have had some issues with passing the arrow catheters through the peripheral nerve block tray tuohy.The arrow catheters have been reported to me as being flimsier than previously.Seems to reach a weak point at 13-15 cm.We had an issue passing the catheter, changed then catheter (did not help) then we changed the tuohy (i pulled a separate sterile tuohy), and it was ok.I also just heard that about 1 week ago the catheter could not pass and would not pull out of the tuohy, so the entire needle and catheter was removed together.Just wanted to report that this has been occurring for some of the doctors.I will save the actual supplies if this occurs again, but i did get lot numbers out of the garbage.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12568392
• MDR Text Key: 274480552
• Report Number: 3006425876-2021-00943
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902139679
• UDI-Public: 10801902139679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: IPN040153
• Device Catalogue Number: EC-05500
• Device Lot Number: 71F21A1854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1