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

Catalog Number	EC-05500
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the epidural catheter became dislodged from the patient's back when he was ambulating." additional information reported the patient underwent imaging and was "discharged home with seemingly no adverse events".It was determined there was no remaining pieces of the catheter inside the patient.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the epidural catheter became dislodged from the patient's back when he was ambulating." additional information reported the patient underwent imaging and was "discharged home with seemingly no adverse events".It was determined there was no remaining pieces of the catheter inside the patient.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4), the customer returned one snaplock assembly and one epidural catheter piece.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter piece revealed the proximal end of the catheter was returned and was intact.The returned catheter piece also reveals 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.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter.The returned catheter extrusion measures approximately 67.5cm.This indicates at least 21.0cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5cm.A device history record review could not be performed as no lot number was provided by the customer.The ifu for this product warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively." the reported complaint of the catheter dislodging from the patient's back could not be confirmed based upon the sample received.The returned catheter piece showed signs of stretching as the extrusion and coil wire were extremely stretched at the likely most distal end.The ifu for this product warns the user never tug or quickly pull on catheter during removal and do not apply additional tension if the catheter begins to stretch as there is a risk for separation.It is unknown how the catheter was handled prior to and during use.Therefore, the potential cause of this complaint could not be determined based on the information provided and the condition of the sample received.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19004647
• Report Number: 3006425876-2024-00298
• Device Sequence Number: 8434635
• Product Code: BSO
• UDI-Device Identifier: 00801902003447
• UDI-Public: 00801902003447
• 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,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: EC-05500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• 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: 04/01/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/05/2024
• 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: Male