MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; RESERVOIR,SUCTION,100CC,SILICONE

Catalog Number	DYNJWE1305
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have experienced issues with drain bulbs not holding suction" and "the drain system is not holding a seal at the junction just above the body of the bulb.".
Additional Manufacturer Narrative
The customer/reporter described 2 eaches of the suction reservoir/bulb evacuator leaking near the top, and clinical staff reported the drain system was not holding a seal at the junction just above the body of the bulb; no injuries reported.Samples were provided by the customer, and visual and functional inspection was conducted.It was found that the top of the bulb was not secure and allowing leaking to occur; this complaint has been confirmed.Cannot determine cause w/received sample; investigations and corrective actions are ongoing with the manufacturer, any defective product has been removed from stock, and the division will continue to monitor for additional trends and will take actions as necessary.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: RESERVOIR,SUCTION,100CC,SILICONE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899109
• Report Number: 1417592-2026-51109
• Device Sequence Number: 10758711
• Product Code: GCY
• UDI-Device Identifier: 40080196966210
• UDI-Public: 40080196966210
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: DYNJWE1305
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2023
• 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: 02/13/2023
• 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): 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