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

Catalog Number	DYNJ88154
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported finding syringe cracked.No sample or photo received for our investigation; the packs production record was reviewed and there were no line down situations, deviations, or non-conformance reports that might have had an impact on this issue, and review of the bill of materials noted that there were no syringe components noted to have been pulled for the production run.Additionally, the rep was contacted and confirmed that the cracked syringe that was reported for this complaint was not pulled from the pack.The cause code was adjusted to unconfirmed defect with item not in kit bom, and the division 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.
Event or Problem Description
It was reported that they had a syringe split on the side while in use.

• Brand Name: MEDLINE
• Common Device Name: DBD-CATH LAB PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50275399
• Report Number: 1417592-2026-17875
• Device Sequence Number: 9698035
• Product Code: OES
• UDI-Device Identifier: 10198459110252
• UDI-Public: 10198459110252
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/14/2026

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: DYNJ88154
• Device Lot Number: 24IMD521
• Was Device Available for Evaluation?: No
• 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: 06/11/2025
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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