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

Catalog Number CA-02220

Device Problem Material Separation (1562)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that: upon using the catheter, the catheter actually separated, and the ends appeared frayed.The patient received p prophylactic antibiotics and was reported as good after the issue.There was no other reported patient harm or consequence.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: upon using the catheter, the catheter actually separated, and the ends appeared frayed.The patient received p rophylactic antibiotics and was reported as good after the issue.There was no other reported patient harm or consequence.

Manufacturer Narrative

(b)(4) the customer reported the catheter separated during use.The customer returned one flat filter, one snaplock assembly and two epidural catheter pieces.The returned components were visually examined with and without magnification.Visual examination of the returned flat filter and snaplock assembly revealed both components appear typical with no observed defects or anomalies.Visual examination of the returned catheter pieces revealed on the likely most proximal piece, the extrusion and coil wire are stretched at the likely distal end with the coil wire extending approximately 9cm 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 4.9cm beyond the extrusion.Also, both the proximal and distal ends of the returned catheter pieces appear to be intact.The catheter appears to have been used as adhesive can be seen on the other extrusion.No other defects or anomalies were observed.The customer also provided photos that appear to show a separated catheter and a lidstock.A dimensional inspection was performed on the catheter using a ruler.The proximal end catheter extrusion piece measures approximately 9.5cm.The distal end catheter piece measures approximately 84.4cm.Both catheter pieces combine to measure approximately 93.9cm.None of the catheter appears to be missing.However, with the coils and extrusion being stretched, this is why the catheter is outside of the 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 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.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 separating during use was confirmed based upon the sample received.The customer returned two catheter pieces that were separated at the extrusion.None of the catheter appeared to be missing.At the point of separation, the extrusion and coil wire are 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.

• 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: 18933417
• MDR Text Key: 338305761
• Report Number: 9680794-2024-00237
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902126358
• UDI-Public: 10801902126358
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CA-02220
• Device Lot Number: 33F23H0251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Female