MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SUTURE REMOVAL TRAY

Catalog Number	DYNJ07254A
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Align (2522); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gauze are light weight and blow off the patient," "gauze get wet, stick to the patient and tear easily," "scissors are difficult to use and have to use more force to get them to cut," "scissors are not lined up correctly," and "needle holders will not hold sutures well.".
Additional Manufacturer Narrative
The account reported finding poor quality gauze, scissors, and needleholder; the customer stated that gauze are light weight and blow off the patient, gauze get wet, stick to the patient and tear easily, scissors are difficult to use and are not lined up correctly, and needle holders will not hold sutures well.A sample was received, and the account returned an unused kit; upon initial inspection of each component, no visual defects were noted, and a functional assessment was done on the scissors, cutting different materials such as paper and gauze.No defects were noted, no functional defects were noted on the other components, finished good production records showed no run without approvals, deviations or non-conformance reports, and finished good pack build had no issues that likely contributed to the reported issue.The reported issues were unable to be confirmed with the sample received, and the root cause was determined to be customer preference; overall, no visual or functional defects were observed after testing.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: SUTURE REMOVAL TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50887217
• Report Number: 1417592-2026-50366
• Device Sequence Number: 16141002
• Product Code: LRO
• UDI-Device Identifier: 40080196039655
• UDI-Public: 40080196039655
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: DYNJ07254A
• Device Lot Number: 23FBF572
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/03/2024
• 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: 03/26/2024
• Initial Report FDA Received Date: 09/24/2026
• 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