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

Model Number	IPN046629
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the epidural catheter was removed, outside of the patient's body, it broke in two different spots.All broken pieces were accounted for.No patient harm or injury.Patient status is reported as "ok".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one snaplock assembly and two epidural catheter pieces.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 pieces revealed on the likely most proximal piece, the coil wire is extremely slightly stretched at the likely distal end as the wire stretches approximately 10cm 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 with the coil wire extending approximately 10mm beyond the extrusion.The proximal end of the returned catheter appears to be intact, however, the distal end appears to have been cut.The catheter appears to have been used as biological material can be seen on the inner coils.No other defects or anomalies were observed.The customer also provided a photo that appear to show a separated epidural catheter.A dimensional inspection was performed on the catheter using a ruler.The proximal end catheter extrusion piece measures approximately 29.7cm.The distal end catheter piece measures approximately 12.7cm.Both catheter pieces combine to measure approximately 42.4cm.This indicates at least 46.1cm of the extrusion is missing as the spe cification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5cm per graphic.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 epidural catheter breaking during use was confirmed based upon the sample received.The customer returned two catheter pieces that were separated at the extrusion.Part of the returned catheter appeared to be missing as the distal tip appeared to have been cut.At the point of separation, the coil wire is extremely stretched on the likely proximal piece and is also stretched on the likely distal piece.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.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.Other remarks: n/a, corrected data: n/a.
Event or Problem Description
It was reported that when the epidural catheter was removed, outside of the patient's body, it broke in two different spots.All broken pieces were accounted for.No patient harm or injury.Patient status is reported as "ok".

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16819428
• Report Number: 1036844-2023-00035
• Device Sequence Number: 19315550
• Product Code: BSO
• UDI-Device Identifier: 10801902013696
• UDI-Public: 10801902013696
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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 Model Number: IPN046629
• Device Catalogue Number: SJ-05501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/01/2023
• 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
• Patient Sex: Unknown