MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETERIZATION SET: 19 GA; ANESTHESIA CONDUCTION CATHETER

Catalog Number	EC-05400-E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "unable to inject fluid after placement in patient, clogged line".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "unable to inject fluid after placement in patient, clogged line".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).Retraction: disgussion with the complaints team and an additional review of the information in this complaint indicates that this was not a reportable event, thus, the initial mdr submitted on (08/15/2024) and also the follow iup mdr submitted on (09/09/2024) should be retracted.Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "unable to inject fluid after placement in patient, clogged line".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ARROW EPIDURAL CATHETERIZATION SET: 19 GA
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19992257
• Report Number: 9680794-2024-00784
• Device Sequence Number: 20601772
• Product Code: BSO
• UDI-Device Identifier: 30801902126383
• UDI-Public: (01)30801902126383(11)231120(17)251031(10)71F23L0451(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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: 10/31/2025
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 71F23L0451
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 09/06/2024; Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/09/2024; 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown