MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN919609
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were issues pushing fluids through the catheter.They were unable to push fluids though the catheter or it was very difficult.Additional information: the 3 catheters were used on 3 different patients during 3 different events.2 were replaced with needle puncture and 1 was not replaced due to lack of time and urgency of the situation.The patient received nitrous oxide instead.The catheters were not tested for flow prior to placement.To do so requires significant force on the snaplock and is not routine clinical practice.Until this issue is fully interrogated i have transitioned to checking flow prior to placement but this is very much not ideal and not something i would recommend as a long term solution.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).The customer returned one snaplock assembly and an epidural catheter.The returned components were received connected together.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 the catheter appears used.Biological material can be seen between the inner coils and adhesive can be seen on the outer extrusion.No other defects or anomalies were observed.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.10.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 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 17.2 ml/min, which is within the specification of 1 ml/min minimum.No blockages were found.The reported complaint of the medical agent not pushing through the catheter could not be confirmed based on the sample received.The returned components passed a functional flow test and met flow rate specifications.A device history record review could not be performed as no lot number was provided by the customer.There were no functional issues found with the returned sample.No further action is required at this time.
Event or Problem Description
It was reported that there were issues pushing fluids through the catheter.They were unable to push fluids though the catheter or it was very difficult.Additional information: the 3 catheters were used on 3 different patients during 3 different events.2 were replaced with needle puncture and 1 was not replaced due to lack of time and urgency of the situation.The patient received nitrous oxide instead.The catheters were not tested for flow prior to placement.To do so requires significant force on the snaplock and is not routine clinical practice.Until this issue is fully interrogated i have transitioned to checking flow prior to placement but this is very much not ideal and not something i would recommend as a long term solution.
Event or Problem Description
It was reported that there were issues pushing fluids through the catheter.They were unable to push fluids though the catheter or it was very difficult.Additional information: the 3 catheters were used on 3 different patients during 3 different events.2 were replaced with needle puncture and 1 was not replaced due to lack of time and urgency of the situation.The patient received nitrous oxide instead.The catheters were not tested for flow prior to placement.To do so requires significant force on the snaplock and is not routine clinical practice.Until this issue is fully interrogated i have transitioned to checking flow prior to placement but this is very much not ideal and not something i would recommend as a long term solution.
Additional Manufacturer Narrative
(b)(40.Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
(b)(4).The lot number has been provided by the customer.A device history record (dhr) review was performed on the reported lot number and no relevant findings were identified.
Event or Problem Description
It was reported that there were issues pushing fluids through the catheter.They were unable to push fluids though the catheter or it was very difficult.Additional information: the 3 catheters were used on 3 different patients during 3 different events.2 were replaced with needle puncture and 1 was not replaced due to lack of time and urgency of the situation.The patient received nitrous oxide instead.The catheters were not tested for flow prior to placement.To do so requires significant force on the snaplock and is not routine clinical practice.Until this issue is fully interrogated i have transitioned to checking flow prior to placement but this is very much not ideal and not something i would recommend as a long term solution.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16133083
• Report Number: 1036844-2023-00005
• Device Sequence Number: 20713841
• Product Code: BSO
• UDI-Device Identifier: 10801902189117
• UDI-Public: 10801902189117
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/27/2022

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: 02/01/2024
• Device Model Number: IPN919609
• Device Catalogue Number: AK-05502
• Device Lot Number: 37F22G0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/10/2023; 02/20/2023; 04/18/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/13/2023; 02/21/2023; 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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