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

Catalog Number	MDS9380LF
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the air is exiting the top of if the pump instead og going into the hose".
Additional Manufacturer Narrative
The customer reported that the medline handheld aneroid had "air is exiting top of pump" and "the air is exiting the top of if the pump instead of going into the hose." medline received one used handheld aneroid sample and tested the sample according to the instructions for use; when attempting to inflate the cuff, the inflation bulb would not inflate the cuff as intended, and after using a control inflation bulb, the cuff inflated up to 300 mmhg and no issues were observed during testing.The complaint was confirmed.The issue shown via investigation was caused due to a defective inflation bulb, as a result of the air mechanism being blocked, preventing it from properly inflating/deflating the cuff; the sample did not work as intended, the vendor has been informed, and medline 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: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884073
• Report Number: 1417592-2026-49942
• Device Sequence Number: 9939825
• Product Code: DXQ
• UDI-Device Identifier: 10080196738922
• UDI-Public: 10080196738922
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/23/2026

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: 65124110001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2025
• 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: 08/14/2025
• Initial Report FDA Received Date: 09/24/2026
• 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