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

Catalog Number	JC-05400-B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the epidural catheter was found with a leak of fluid at the level of the puncture site.The epidural thread was removed and it was found that the fluid was leaking from the tip of the catheter (which is normal) but also leaking about 10cm from the tip, which is not normal." no patient harm or injury.The patient's current conditon is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of the catheter leaking was confirmed based on evaluation of the sample received.During the functional inspection, the returned epidural catheter was confirmed to leak from where the catheter was damaged at approximately 12.8cm from the distal end.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review could not be performed as no lot number was provided by the customer.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 " the epidural catheter was found with a leak of fluid at the level of the puncture site.The epidural thread was removed and it was found that the fluid was leaking from the tip of the catheter (which is normal) but also leaking about 10cm from the tip, which is not normal." no patient harm or injury.The patient's current conditon is reported as "fine".

• Brand Name: ARROW 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19013791
• Report Number: 3006425876-2024-00312
• Device Sequence Number: 19789670
• Product Code: BSO
• UDI-Device Identifier: 40801902029674
• UDI-Public: 40801902029674
• 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,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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 Catalogue Number: JC-05400-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown