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

Catalog Number	MDS9380LF
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "not inflating- bulb sticks.".
Additional Manufacturer Narrative
The customer reported receiving a medline hand held aneroid that has a bulb with a bearing that gets stuck causing the aneroid to not inflate; there was no reported death or serious injury associated with this event.Medline received 1ea hand held aneroid, visually inspected the sample and found no obvious signs of defects, and attempted to inflate the cuff to 300mmhg; however, the cuff did not inflate due to the bulb.The complaint was confirmed; the bulb would not depress due to the bearing inside not releasing the air as intended, and the cause was documented as comp./part defective, broke.The issue falls under a known inflation issue, medline is working with the vendor to implement the necessary corrective actions, and the division will continue to monitor 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: ANEROID,HAND HELD,ADULT,NEOPRENE
• 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: 50889552
• Report Number: 1417592-2026-50533
• Device Sequence Number: 10664416
• Product Code: DXQ
• UDI-Device Identifier: 10080196738922
• UDI-Public: 10080196738922
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K211084
• 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): 09/24/2026

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: MDS9380LF
• Device Lot Number: 65124020001
• 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: 08/07/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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