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

Model Number	IPN920769
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the insertion of an epidural catheter in the operating room, when the [operator] connected the lor syringe, the [operator] noticed that the plunger was not sealed properly and that it led to a physiological serum leak all around the plunger.The syringe was impossible to use.We changed the kit".At the time of this report, the customer has not returned our requests for additional information.The complaint file will be updated if further information is received.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "during the insertion of an epidural catheter in the operating room, when the [operator] connected the lor syringe, the [operator] noticed that the plunger was not sealed properly and that it led to a physiological serum leak all around the plunger.The syringe was impossible to use.We changed the kit".At the time of this report, the customer has not returned our requests for additional information.The complaint file will be updated if further information is received.
Additional Manufacturer Narrative
(b)(4).The customer reported the lor syringe leaked.The customer returned one 10ml plastic lor syringe and lidstock.The syringe was visually examined with and without magnification.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 luer 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 leaking 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.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Additional information received from the customer indicates the "patient is fine, no complications.Another kit was used." it was also reported that "the position of the needle tip was impossible to predict, liquid started flowing around the plunger 2-3 cm from the skin." and "the procedure was stopped once the leak was detected, the epidural space being impossible to identify.".Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "during the insertion of an epidural catheter in the operating room, when the [operator] connected the lor syringe, the [operator] noticed that the plunger was not sealed properly and that it led to a physiological serum leak all around the plunger.The syringe was impossible to use.We changed the kit".

• 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
• MDR Report Key: 16776564
• Report Number: 3006425876-2023-00456
• Device Sequence Number: 20501053
• Product Code: BSO
• UDI-Device Identifier: 00801902062512
• UDI-Public: 00801902062512
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2023

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: 04/30/2024
• Device Model Number: IPN920769
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F22E1927
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 05/19/2023; 05/19/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/26/2023; 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2022
• 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