MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION SET NRFIT

Catalog Number EJ-05400-NRO

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.

Event Description

The user was unable to insert the catheter into the epidural needle smoothly because of resistance.Therefore, a new kit was used instead.

Event Description

The user was unable to insert the catheter into the epidural needle smoothly because of resistance.Therefore, a new kit was used instead.

Manufacturer Narrative

Qn# (b)(4).A lot number was not provided.A device history record review was performed based upon a potential lot number.A device history record review was performed on the epidural catheter and needle with no relevant findings.A design history review was performed for part # jz-05500-004n and kz-005400-030 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could 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.A lot number was not provided.A device history record review was performed based upon a potential lot number.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• 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: 14305054
• MDR Text Key: 296049177
• Report Number: 3006425876-2022-00394
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EJ-05400-NRO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• 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