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

Catalog Number JC-05400-B

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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".

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 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
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19013791
• MDR Text Key: 339254598
• Report Number: 3006425876-2024-00312
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 40801902029674
• UDI-Public: 40801902029674
• 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,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.