MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; ANESTHESIA CONDUCTION CATHETER

Catalog Number	JC-05400-E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported that: "postpartum patient who received evaluation from an anesthesiologist , who performed the epidural catheter removal on which presents rupture, leaving a fragment of the catheter in the left foraminal location in l3/l4 in contact with the l3 emerging root, according to a lumbar spine ct scan report." awaiting additional information from the customer.
Event or Problem Description
It was reported that: "postpartum patient who received evaluation from an anesthesiologist , who performed the epidural catheter removal on which presents rupture, leaving a fragment of the catheter in the left foraminal location in l3/l4 in contact with the l3 emerging root, according to a lumbar spine ct scan report." awaiting additional information from the customer.
Additional Manufacturer Narrative
(b)(4), the reported complaint of epidural catheter breaking during removal was confirmed based upon the investigation of the sample received.The customer returned one flat filter, one catheter adapter and one epidural catheter piece.The returned components were visually examined with and without magnification.Visual and dimensional examination of the returned catheter piece revealed signs of stretching.The extrusion and coil wire are extremely stretched at the likely most distal end of the catheter as the distal tip is not intact and was not returned.The returned catheter appears used as biological material can be seen between the inner coils and adhesive material can be seen on the outer extrusion.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 with no relevant findings.Based upon the condition of the sample received and the observed evidence of the extrusion and coil wire stretching at the distal end, unintentional user error caused or contributed to this event.

• Brand Name: ARROW ACCESS TRAY
• 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: 20342759
• Report Number: 3006425876-2024-00949
• Device Sequence Number: 15440100
• Product Code: BSO
• UDI-Device Identifier: 30801902126420
• UDI-Public: (01)30801902126420(11)230817(17)250731(10)71F23H0889(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Expiration Date: 07/31/2025
• Device Catalogue Number: JC-05400-E
• Device Lot Number: 71F23H0889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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 Age: 27 YR
• Patient Sex: Female