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

Catalog Number AK-05503-L

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "end of catheter broke off and was left in patient upon removal.An xray came back negative when staff inspected for remaining catheter.Patient discharged." no patient harm or injury.The patient's current condition is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The customer reported the catheter broke during removal.The customer returned one snaplock assembly and an epidural catheter.The returned components were received connected together.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the extrusion and coil wire are stretched at the distal end with the coil wire extending approximately 17cm beyond the extrusion.Both the proximal and distal ends of the returned catheter appear to be intact.The catheter appears to have been 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 catheter.The returned catheter extrusion measures approximately 90.9.None of the catheter appears to be missing.The catheter is within specification of 88.5-91.5 cm per graphic.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit 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.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal." the reported complaint of catheter breaking during removal was confirmed based upon the sample received.Visual examination of the returned sample revealed extrusion and coil wire were stretched at the distal end with the coil wire extending approximately 17cm beyond the extrusion.None of the catheter appeared to be missing.The ifu for this product warns the user to never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Therefore, based upon the condition of the sample received , unintentional user error caused or contributed to this event.No further action is required at this time.

Event Description

It was reported "end of catheter broke off and was left in patient upon removal.An xray came back negative when staff inspected for remaining catheter.Patient discharged." no patient harm or injury.The patient's current condition is reported as "fine.".

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19077960
• MDR Text Key: 339789240
• Report Number: 9680794-2024-00327
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 70801902005150
• UDI-Public: 70801902005150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: AK-05503-L
• Device Lot Number: 33F23H0866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2023
• 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
• Patient Sex: Female