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

Catalog Number	MDS9388LF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guage is stuck at 300 and will not move.This was noticed right after unboxing the item.
Additional Manufacturer Narrative
The customer called in to advise that the guage is stuck at 300 and will not move, and this was noticed right after unboxing the item; customer also explained that there were not signs of shipping damage.Upon a visual inspection of the sphygmomanometer, the dial was off from the start position; a calibration tool was used to calibrate the unit, and after positioning the needle, a control cuff was inflated up to 300 mmhg for three times and no issues were experienced.The complaint was not confirmed, and the samples worked as intended.Cause code description was not confirmed with received sample; the division has been informed and 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,LRG ADULT,NEOPRENE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896322
• Report Number: 1417592-2026-50719
• Device Sequence Number: 10684679
• Product Code: DXQ
• UDI-Device Identifier: 10080196738953
• UDI-Public: 10080196738953
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: MDS9388LF
• Device Lot Number: 65123100001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2024
• 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: 04/10/2024
• Initial Report FDA Received Date: 09/25/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown