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

Model Number IPN046313

Device Problem Obstruction of Flow (2423)

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

Event Date 12/08/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

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

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.

Event 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: 3006425876-2022-01138, 3006425876-2022-01139, 3006425876-2022-01140, 3006425876-2022-01141, 3006425876-2022-01137.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: 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: 15971756
• MDR Text Key: 306799578
• Report Number: 3006425876-2022-01142
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00801902062512
• UDI-Public: 00801902062512
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: IPN046313
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F22K0259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.