MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TEST,HCG,PREGNANCY,URINE,CASS, 25 MIU

Catalog Number	MPH12025HCG
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿(b)(6) is concerned about the pregnancy test with lot number hcg2022015.She has got three faintly positive.¿.
Additional Manufacturer Narrative
The customer reported concern about the pregnancy test because ¿she has got three faintly positive,¿ and additional information stated the reason for the test was ¿prior to iud insertion¿; no adverse patient, fetus, or user event, no delay in a medical procedure or treatment, no treatment/procedure provided or withheld based on the result, ¿none¿ for impact, and no adverse patient outcomes were reported.Complaint could not be confirmed as there were no samples or pictures received; retained devices from the reported lot number were tested with hcg-negative clinical urine samples, the results were read at 3 and 4 minutes, and all devices yielded the expected negative results with no false positive results observed during in-house testing.The reported issue was not replicated during testing of retention product, and a root cause could not be determined from the available information.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified; manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.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: TEST,HCG,PREGNANCY,URINE,CASS, 25 MIU
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50689505
• Report Number: 1417592-2026-34596
• Device Sequence Number: 5891678
• Product Code: JHI
• UDI-Device Identifier: 30888277191871
• UDI-Public: 30888277191871
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• 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): 09/04/2026

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: MPH12025HCG
• Device Lot Number: HCG2022015
• 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: 09/08/2023
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown