MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION SET: 19 GA; ANESTHESIA CONDUCTION CATHETER

Catalog Number	EC-05400-E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that"(b)(6) 2024, after placing into the patient's body, when injecting the liquid, it was found that the upper section of the return window was leaking, so it was removed and the patient's body fluid end was clipped to provide complaints.There was no reported patient harm or consequence.A new device was used.".
Additional Manufacturer Narrative
(b)(4).The customer reported the catheter was leaking.The customer returned one 25ml injection syringe, one flat filter, one snaplock assembly, and an epidural catheter piece.The returned filter, snaplock, and catheter piece were returned connected together.The returned sample was visually examined with and without magnification.Visual examination of the returned syringe, filter, and snaplock revealed these components appear typical with no observed defects or anomalies.Visual examination of the returned catheter revealed part of the catheter is missing as the catheter appears to have been cut at the distal end.The catheter appears to have been used as biological material between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a ruler.The returned catheter extrusion measures approximately 14.2cm.This indicates at least 74.3cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5cm.Functional inspection was performed on the returned sample.A functional leak test was performed using the returned catheter piece and the returned snaplock assembly with a leak tester.The proximal end of the catheter was inserted into the snaplock assembly until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock assembly was then connected to the leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from approximately 9.5cm from the proximal end.Microscopic examination revealed the catheter was damaged at that location.No other leaks were detected.A device history record review was performed on the epidural needle and epidural catheter with no relevant findings.The ifu cautions the user, "do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." the reported complaint of the catheter leaking was confirmed based on evaluation of the sample received.Visual and dimensional inspection revealed only 14.2cm of the catheter was returned as the catheter appeared to have been cut at the distal end.During the functional inspection, the returned epidural catheter was confirmed to leak at approximately 9.5cm from the proximal end where the catheter appears to be damaged.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed on the epidural catheter with no relevant findings.The leak was detected during use.Therefore, based on the time of discovery and the condition of the sample received, unintentional user error caused or contributed to this event.No further action is required at this time.
Event or Problem Description
It was reported that"19 july 2024, after placing into the patient's body, when injecting the liquid, it was found that the upper section of the return window was leaking, so it was removed and the patient's body fluid end was clipped to provide complaints.There was no reported patient harm or consequence.A new device was used.".

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19990128
• Report Number: 9680794-2024-00781
• Device Sequence Number: 12869850
• Product Code: BSO
• UDI-Device Identifier: 30801902126383
• UDI-Public: (01)30801902126383(11)231120(17)251031(10)71F23L0451(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 10/31/2025
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 71F23L0451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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