MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MANIFOLD,ASM,1V,RH/OFF,PERC.,PG

Catalog Number	000000000070038107
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there was a tvlb procedure on 8/19 where dr.(b)(6) was taking pressures with manifold 70038107 and was getting negative readings.".
Additional Manufacturer Narrative
The customer reported that during a tvlb procedure, dr.Rilling was taking pressures with the manifold and was getting negative readings; he switched to a new manifold and the numbers were positive and appropriate for what would be expected in the liver.A used sample was returned for evaluation; visual evaluation of the returned sample did not reveal any defects, and ert testing was performed with the sample failing testing for sensitivity, zero offset pressure, and r-cal because the sensor is damaged and not getting correct output voltage.Based on the investigation results, the reported event was confirmed for damage to the sensor.A root cause as to why the sample did not respond when under pressure could not be determined, and medline will continue to monitor for additional occurrences and adverse trends.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: MANIFOLD,ASM,1V,RH/OFF,PERC.,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50935141
• Report Number: 1417592-2026-53459
• Device Sequence Number: 10759823
• Product Code: DRS
• UDI-Device Identifier: 20193489064947
• UDI-Public: 20193489064947
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K902472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Device Catalogue Number: 000000000070038107
• Device Lot Number: 0000114296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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