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

Model Number	IPN040153
Medical Device Problem Codes	Material Fragmentation (1261); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional 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 or Problem 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
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13586785
• Report Number: 3006425876-2022-00201
• Device Sequence Number: 20001951
• Product Code: BSO
• UDI-Device Identifier: 10801902139679
• UDI-Public: 10801902139679
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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: IPN040153
• Device Catalogue Number: EC-05500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown