MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX FILTER SET; FILTER, INFUSION LINE

Model Number MX448HFB

Device Problem No Flow (2991)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that the iv fluid is not running through the administration set.There was no patient injury reported.

Manufacturer Narrative

One filter set was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.

Manufacturer Narrative

This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Sample went through water leak and occlusion test and it did not exhibit leakage or occlusion condition.The root cause of the reported issue cannot be determined, as the returned sample did not exhibited occlusion nor defective condition.Actions were taken to mitigate the reported issue: awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held.No problems or issues were identified during this device history record review.

Manufacturer Narrative

Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Sample went through water leak and occlusion test and it did not exhibit leakage or occlusion condition.The root cause of the reported issue cannot be determined, as the returned sample did not exhibited occlusion nor defective condition.Actions were taken to mitigate the reported issue: awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held.No problems or issues were identified during this device history record review.

• Brand Name: MEDEX FILTER SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13672452
• MDR Text Key: 286772296
• Report Number: 3012307300-2022-04347
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX448HFB
• Device Catalogue Number: MX448HFB
• Device Lot Number: 4180739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1