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

Model Number	IPN040153
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3006425876-2021-00943
• Device Sequence Number: 3420494
• Product Code: BSO
• UDI-Device Identifier: 10801902139679
• UDI-Public: 10801902139679
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown