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

Model Number IPN920780

Device Problem Pressure Problem (3012)

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

Event Date 12/28/2022

Event Type  malfunction  

Event Description

Reported event: during the insertion of the epidural catheter, we observed that the lor syringe was presenting a resistance during its use.There was no injury reported.

Manufacturer Narrative

Qn#(b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is completed.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4).The customer returned one 10ml plastic lor syringe nrfit and lidstock.The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.Functional testing was performed on the returned syringe using the lab leak tester per the parameters in amrq-000155, rev.8, section 7.2-positive pressure leakage.Water was aspirated into the syringe to the 10ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.No leaks were detected.The plunger was rotated 45deg and the syringe was once again tested at 10psi for 10 seconds and no leaks were detected.This was performed by rotating the plunger 45deg until the plunger had rotated a full 360deg with no leaks detected.Water was removed from the syringe to the 2ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds with the plunger being rotated 45deg until it had rotated a 360deg with no leaks being detected.The returned lor syringe was compared to a lab inventory syringe by sliding the plunger into the barrel of the syringe.The resistance of the returned lor syringe was comparable to the lab inventory syringe.The nrfit end of the returned syringe was capped.With the tip sealed, the lor syringe was tested for leaks by pushing the plunger into the barrel.This was performed at 8ml, 5ml, and 2ml by pushing the plunger and rotating 45deg until the plunger had rotated a full 360deg.No leaks or slippage of the plunger occurred.An attempt to remove the plunger from the barrel was performed.The plunger seal snapped back when attempting to remove from the barrel.This was also performed with a lab inventory syringe with the same results.This indicates the plunger seal was creating a vacuum with no issues.A device history record review was performed on the lor syringe with no relevant findings.The reported complaint of the lor syringe presenting a resistance issue 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.

Event Description

Reported event: during the insertion of the epidural catheter, we observed that the lor syringe was presenting a resistance during its use.There was no injury reported.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• 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: 16233966
• MDR Text Key: 308574835
• Report Number: 3006425876-2023-00050
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902197730
• UDI-Public: 10801902197730
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

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: IPN920780
• Device Catalogue Number: OT19TKPSS
• Device Lot Number: 71F22K2553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• 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