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

Model Number	MX448HFB
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the iv fluid is not running through the administration set.There was no patient injury reported.
Additional 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-04347
• Device Sequence Number: 5375485
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2023

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 Expiration Date: 09/27/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 02/03/2023; 02/03/2023
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 03/15/2023; 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown