MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANEROID,HAND HELD,ADULT

Catalog Number	MDS9380
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr summary report covers malfunction events that occurred in q3 of 2025.The report summarizes 8 malfunction events involving sphygmomanometers (mds9380).Customer reported that "cuffs are defective, the inflation bulb is not working it gets stuck together while taking blood pressure.".
Additional Manufacturer Narrative
This vmsr summary report covers malfunction events that occurred in q3 of 2025.The report summarizes 8 malfunction events involving sphygmomanometers (mds9380).Customer reported that "cuffs are defective, the inflation bulb is not working it gets stuck together while taking blood presure." associated serial numbers: (b)(6).Associated di: (b)(4).Lot number 65122030002, 65124090002, and 65125020002.Medline received 8 samples, tested each sample for inflation to 300mmhg, and switched bulbs to other cuffs to test that the bulbs worked once removed and switched.All bulbs were able to inflate multiple cuffs and medline did not experience any bulb getting stuck while inflating; however, one cuff did experience leakage.The reported bulb issue was not confirmed, one cuff leakage was confirmed, and the cause was identified as comp./part defective, broke; there has been no change to the reportability decision associated with this complaint.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: ANEROID,HAND HELD,ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50916250
• Report Number: 1417592-2026-52121
• Device Sequence Number: 5330502
• Product Code: DXQ
• UDI-Device Identifier: 10080196717743
• UDI-Public: 10080196717743
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211084
• Exemption Number: VMSR
• Number of Events Summarized: 8
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: MDS9380
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2025
• 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: 08/05/2025
• Initial Report FDA Received Date: 09/28/2026
• 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