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

Catalog Number	JC-05400-E
Medical Device Problem Codes	Corroded (1131); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Purulent Discharge (1812)
Date of Event	02/25/2024
Type of Reportable Event	Serious Injury
Event or Problem 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".
Additional Manufacturer Narrative
(b)(4).
Additional 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 or Problem 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
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19004580
• Report Number: 3006425876-2024-00313
• Device Sequence Number: 9420449
• Product Code: BSO
• UDI-Device Identifier: 30801902126420
• UDI-Public: 30801902126420
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/29/2024
• 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