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

Model Number	IPN046313
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
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
It was reported that immediately after placement, 6 catheters on 6 different patients were non passable (occluded) and had to be replaced.The 6 events occurred in (b)(6) 2022, the exact date is unknown in each case.A patient was not harmed, each catheter was replaced immediately without an issue.
Event or Problem Description
It was reported that immediately after placement, 6 catheters on 6 different patients were non passable (occluded) and had to be replaced.The 6 events occurred in december 2022, the exact date is unknown in each case.A patient was not harmed, each catheter was replaced immediately without an issue.Associated mdrs: 3006425876-2022-01139, 3006425876-2022-01140, 3006425876-2022-01141, 3006425876-2022-01142, 3006425876-2022-01137.
Additional Manufacturer Narrative
(b)(4).The customer reported the catheter was occluded.The customer returned one epidural catheter.The returned sample was visually examined with and without magnification.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen on 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 a lab inventory 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 8.0ml/min, which is within the specification of 1ml/min minimum.No blockages were found.A device history record review was performed on the epidural catheter with no relevant findings.The reported complaint of the catheter being occluded could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned sample passed a functional flow test and met flow rate specifications.There were no functional issues found with the returned sample.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 15971614
• Report Number: 3006425876-2022-01138
• Device Sequence Number: 6404632
• Product Code: BSO
• UDI-Device Identifier: 00801902062512
• UDI-Public: 00801902062512
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 09/30/2024
• Device Model Number: IPN046313
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F22K0259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown