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

Model Number	IPN920760
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " no loss of resistance with the syringe plunger.I can confirm the occurrence of a breach with clinical.Manifestations such as headache and neck pain.Patient discharged on (b)(6) 2025.Required 3 blood patches on(b)(6).".
Event or Problem Description
It was reported that " no loss of resistance with the syringe plunger.I can confirm the occurrence of a breach with clinical manifestations such as headache and neck pain.Patient discharged on (b)(6) 2025.Required 3 blood patches on (b)(6).".
Additional Manufacturer Narrative
(b)(4).The customer reported " no loss of resistance with the syringe plunger".The customer returned two sealed representative kits from the same lot # as reported on the complaint for investigation.The actual complaint sample was not received.The returned kits were opened, and the plastic lor syringes were removed and were visually examined.Visual examination of the lor syringes revealed both syringes appear typical with no observed defects or anomalies.Functional testing was performed on the returned syringe using the lab leak tester per the parameters positive pressure leakage.For both returned lor syringes, the tip of the syringe was connected to the lab leak tester via tubing and pressure was applied.Water was aspirated into the syringe to the 2ml mark.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 then aspirated into the syringe to the 10ml mark.The syringe was tested at 10psi for 10 seconds with the plunger being rotated 45deg until it had rotated a full 360deg with no leaks being detected.The returned lor syringes were compared to a lab inventory syringe by sliding the plunger into the barrel of the syringe.The resistance for both returned lor syringes was comparable to the lab inventory syringe.The luer end of the returned syringes was capped.With the tip sealed, the lor syringes were 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.A design history review was performed as a part of this complaint investigation.There have been no material changes for this part during the last two years that could have led to this complaint.The reported complaint of "no loss of resistance with the syringe plunger" could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.Both returned lor syringes passed functional testing, including a leak test.Also, both returned lor syringes 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 relevant findings.The investigation found no evidence to suggest a manufacturing related cause.Based on the functional testing, there were no 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21805123
• Report Number: 3006425876-2025-00343
• Device Sequence Number: 15653164
• Product Code: BSO
• UDI-Device Identifier: 40801902029674
• UDI-Public: (01)40801902029674(11)240827(17)260731(10)71F24H0949(21)
• 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
• Report Date (Section B): 03/18/2025

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: 07/31/2026
• Device Model Number: IPN920760
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F24H0949
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown