MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; FLUORO PACK

Catalog Number	DYNDH2155
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the forceps(straight kellys) broke.".
Additional Manufacturer Narrative
It was reported that the hemostat broke while trying to "squeeze" a needle; no medical intervention, serious injury, or follow-up care has been reported.A sample was received for investigation, one pair of forceps arrived in a biohazard bag, the break was readily identified as the forceps were split into two pieces, and the point of breakage was jagged and not a clean break; device history records, the bill of materials, packaging instructions, account complaint history, and component complaint history were reviewed.Based on the review of the physical sample received, the report of a forceps breaking is confirmed.Due to the component not being altered or manipulated during the production process, the root cause is a vendor product issue relating to the component manufacturing process; given that this is a multi-sourced component, the vendor could not be definitively identified based on the provided information, no further review can be performed, and the division will continue to 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: FLUORO PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50868757
• Report Number: 1417592-2026-48748
• Device Sequence Number: 18486663
• Product Code: LRO
• UDI-Device Identifier: 10198459357701
• UDI-Public: 10198459357701
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/22/2026

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: DYNDH2155
• Device Lot Number: 25EMI627
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2025
• 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: 12/03/2025
• Initial Report FDA Received Date: 09/23/2026
• 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