MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-VITRECTOMY PACK

Catalog Number	DYNJ56586L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had 3 retina packs that came with stopcocks that leaked, after examination under the microscope, a crack was observed on each stopcock.
Additional Manufacturer Narrative
The customer had 3 retina packs that came with stopcocks that leaked, and after examination under the microscope, a crack was observed on each stopcock.A sample was received for investigation; fifteen unused stopcocks were inspected under a microscope and no defects were noted, and all fifteen were tested by connecting a 10 ml syringe full of fluid (water) to the stopcock with no leaking detected or observed from the samples.Based on the complaint details, investigation, and physical samples review and test, the issue reported of leaking could not be duplicated with the samples received and could not be confirmed.The cause was documented as not confirmed with received sample, and the supplier quality team will monitor this issue for trending purposes.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: DBD-VITRECTOMY PACK
• 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: 50734326
• Report Number: 1417592-2026-37020
• Device Sequence Number: 10599813
• Product Code: OJK
• UDI-Device Identifier: 40195327253234
• UDI-Public: 40195327253234
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/08/2026

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: DYNJ56586L
• Device Lot Number: 23HBV171
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/09/2023
• 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: 09/26/2023
• Initial Report FDA Received Date: 09/11/2026
• 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