MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT; SET, I.V. FLUID TRANSFER

Model Number 21-7609-24

Device Problem Crack (1135)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Sample received: one (1) sample was received.The sample consist in one cassette product from part number 21-7609-24.Sample was received without original, package.Functional testing: the sample was test for leak by passing water through it; occlusion was detected in the luer.It was observed part of the syringe in the luer.The complaint is confirmed.Root cause: based on the analysis conducted in the sample provided, and the instructions for use the is that product become damaged during use.Action taken: production personnel was notified by quality engineer on (b)(6) 2021 of the defect reported by the customer.

Event Description

It was reported that during the use of the product, the syringe tip broke off and got caught in the connector.No patient injury was reported.

• Brand Name: NRFIT
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 13361692
• MDR Text Key: 285749929
• Report Number: 3012307300-2022-01829
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044014
• UDI-Public: 10610586044014
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7609-24
• Device Catalogue Number: 21-7609-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1