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

Catalog Number	DYNJ62860C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported finding broken hemostats.A photo was received for investigation, finished good production records were reviewed, and finished good pack build was reviewed; the photo depicts the broken hemostat, with one jaw detached and the break occurring completely at the box lock of the hemostat forceps.Based on the received photo, medline was able to confirm the reported issue, and further investigation reveals that the root cause is attributed to a vendor product issue related to the component manufacturing process.The vendor determined a likely root cause to be from the manufacturing process, stating it is likely a crack formed on the jaw of the instrument that was missed during final inspection, which led to the instrument breaking; a risk assessment has been completed and the incident was found to be acceptable, and there has been no change to the reportability decision associated with this complaint.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 "needle nose hemostats broke while radiologist was trying to use them.".

• Brand Name: MEDLINE
• Common Device Name: DBD-RADIOLOGY MINOR PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50275473
• Report Number: 1417592-2026-17882
• Device Sequence Number: 10414969
• Product Code: OES
• UDI-Device Identifier: 40195327265824
• UDI-Public: 40195327265824
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: DYNJ62860C
• Device Lot Number: 24HMC359
• Was Device Available for Evaluation?: Yes
• 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: 12/26/2024
• 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