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

Model Number IPN920609

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Perforation (2001)

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that: the syringe plunger was blocked.There was a breach in the mater which required a blood patch.The issue was identified during use on patient.

Event Description

It was reported that: the syringe plunger was blocked.There was a breach in the mater which required a blood patch.The issue was identified during use on patient.

Manufacturer Narrative

(b)(4).The reported complaint of issues with the lor syringe could not be confirmed based on the sample received.The returned lor syringe passed functional testing, including a leak test.Also, the returned lor syringe when compared to a lab inventory syringe had comparable resistance when sliding the plunger into the barrel of the syringe.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.There were no functional issues found with the returned sample.No further action is required at this time.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: the syringe plunger was blocked.There was a breach in the mater which required a blood patch.The issue was identified during use on patient.

Manufacturer Narrative

(b)(4), correction: section d4 updated the udi # from (b)(4).

• Brand Name: EPIDURAL CATHETERIZATION KIT
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18354592
• MDR Text Key: 330872155
• Report Number: 3006425876-2023-01255
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN920609
• Device Catalogue Number: FR-05501-04
• Device Lot Number: 71F23F2269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/10/2024; Not provided
• Supplement Dates FDA Received: 01/11/2024; 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED; NOT REPORTED