MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-T&A PACK

Catalog Number	DYNJ37266F
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we are having difficulty with the suction cautery in this pack.The scrub tech in that services is telling me that it does not work effectively.".
Additional Manufacturer Narrative
The account reported having difficulty with the suction tubing component that was subbed in place of another component in their t&a pack, and the scrub tech communicated that it does not work effectively.A sample was received; two samples were provided, two sets of tubing were received and one was noted to be longer than the other, finished good production records were reviewed, and the finished good pack build was reviewed.The pack build review found a rep approved substitution that omitted tbg suction 1/4 x 144in and added tbg suction 1/4 x 72in; the reported substitution/length difference was confirmed, and clinical later stated that "the suction tubing difference was length, which is subjective and customer preference." the complaint was updated to reflect dc: traced to user with preference/item to spec, there has been no change to the reportability decision, and the division will continue to monitor this issue for trending.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-T&A PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50858541
• Report Number: 1417592-2026-48115
• Device Sequence Number: 13138634
• Product Code: LRO
• UDI-Device Identifier: 40889942450115
• UDI-Public: 40889942450115
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: DYNJ37266F
• Device Lot Number: 23BBQ338
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2023
• 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: 02/15/2023
• Initial Report FDA Received Date: 09/22/2026
• 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