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

Catalog Number	EC-05500
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "anesthesia inserted an epidural catheter into a patient.The catheter went in smoothly and it was secured with a lockit device.The anesthesiologist then proceeded to draw back on the catheter with a medication syringe and air came into the syringe.They realized something wasn't right with the catheter and so they noticed there was a separation in the catheter.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.".
Additional Manufacturer Narrative
(b)(4).The reported complaint of epidural catheter separating during use was confirmed based upon the sample received.The customer reported the catheter separated during use.The customer returned one catheter adapter, two epidural catheter pieces, and lidstock.Visual examination of the returned catheter pieces revealed on the likely most proximal piece, the extrusion is slightly stretched, and coil wire is extremely stretched at the likely distal end with the coil wire extending approximately 10.7cm beyond the extrusion.The extrusion and coil wire on the likely most distal piece are also stretched at the point of separation at the likely proximal end.The returned catheter appears used as biological material can be seen between the inner coils.Dimensional inspection revealed that approximately 32.8cm of the catheter appeared to be missing.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.A device history record review was performed on the epidural catheter and no relevant findings were identified.Therefore, based upon the condition of the sample received, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that: "anesthesia inserted an epidural catheter into a patient.The catheter went in smoothly and it was secured with a lockit device.The anesthesiologist then proceeded to draw back on the catheter with a medication syringe and air came into the syringe.They realized something wasn't right with the catheter and so they noticed there was a separation in the catheter.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.".

• Brand Name: ARROW EPIDURAL CATHETERIZATION COMPONENT
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20300711
• Report Number: 3006425876-2024-00918
• Device Sequence Number: 12659508
• Product Code: BSO
• UDI-Device Identifier: 00801902003447
• UDI-Public: (01)00801902003447(11)240213(17)260131(10)71F24B0117(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 01/31/2026
• Device Catalogue Number: EC-05500
• Device Lot Number: 71F24B0117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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