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

Model Number IPN040153

Device Problems Material Fragmentation (1261); Material Too Soft/Flexible (4007)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

It seems that the catheter is very elastic until you reach the markings then it is brittle and breaks when pulled.It can be repeated with other catheters that were not used on a patient.I believe two patients, yes standard epidurals for or surgery, no injury thus far.

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4).A device history record review could not be performed as no lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, there was no record of purchase of this product by this customer.A review of design change history for part number kz-05400-030 was performed as a part of this investigation.No design changes have been made to this part in the past two years that would have led to this complaint.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.The device history records were not reviewed as no lot number was provided by the customer and no sales history records could be found for this customer for this product.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.

Event Description

It seems that the catheter is very elastic until you reach the markings then it is brittle and breaks when pulled.It can be repeated with other catheters that were not used on a patient.I believe two patients, yes standard epidurals for or surgery, no injury thus far.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Type of Device: 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13586785
• MDR Text Key: 286065878
• Report Number: 3006425876-2022-00201
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902139679
• UDI-Public: 10801902139679
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN040153
• Device Catalogue Number: EC-05500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1