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

Catalog Number JC-05400-E

Device Problems Corroded (1131); Patient-Device Incompatibility (2682)

Patient Problem Purulent Discharge (1812)

Event Date 02/25/2024

Event Type  Injury  

Event Description

It was reported "the clinician observed a purulent discharge at the puncture site.He then removed the compresses and noticed that the filter was corroded, orange-stained and porous." additional information reports there was no systemic infection and the patient was not septic prior to inserting the catheter.The filter was changed and antibiotics was administered.The patients current condition is reported as "stable".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer reported the filter was corroded.The customer returned one flat filter.The returned sample was visually examined with and without magnification.Visual examination of the returned filter revealed the filter's outer shell is discolored with a white/orange substance as compared to a lab inventory filter.The reported complaint of the filter being corroded was confirmed based on the sample received.During visual examination, the returned filter was discolored with a white/orange substance as compared to a lab inventory filter.Based upon the information provided and the condition of the sample received, the potential cause of this complaint could not be determined.The returned sample will be forwarded to an analysis lab for further evaluation.If the results become available, the investigation will be updated.

Event Description

It was reported "the clinician observed a purulent discharge at the puncture site.He then removed the compresses and noticed that the filter was corroded, orange-stained and porous." additional information reports there was no systemic infection and the patient was not septic prior to inserting the catheter.The filter was changed and antibiotics was administered.The patients current condition is reported as "stable".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19004580
• MDR Text Key: 338937748
• Report Number: 3006425876-2024-00313
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 30801902126420
• UDI-Public: 30801902126420
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JC-05400-E
• 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: 03/05/2024
• Initial Date FDA Received: 03/29/2024
• 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