MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-PIV KIT W/EXTENSION SET

Catalog Number	DYNDV2522A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer was attaching the valve to the female fitting on the extension set when the valve came apart into 4 separate pieces.It appears the valve was not welded during assembly process.
Additional Manufacturer Narrative
The account reported finding component broke; customer was attaching the valve to the female fitting on the extension set when the valve came apart into 4 separate pieces, and patient was not injured.Sample evaluation: two photos and one sample were provided for evaluation; the sample received consisted of one used valve contained in a plastic biohazard bag, finished good production records and finished good pack build were reviewed, and trending was reviewed with 0 additional reported complaint(s) for this issue for the account and component in the past 24 months.Review confirmed the reported issue, as the valve had separated into four individual pieces; no breaks, cracks, or other damage were observed on any of the individual components.While the reported condition was confirmed, the root cause could not be determined at this time, as there was no observable damage to explain why the valve came apart, and the timing and conditions under which this occurred remain unclear; this complaint has been provided to the vendor for further evaluation 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.

• Brand Name: MEDLINE
• Common Device Name: DBD-PIV KIT W/EXTENSION SET
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897191
• Report Number: 1417592-2026-50821
• Device Sequence Number: 17599550
• Product Code: LRS
• UDI-Device Identifier: 10653160382676
• UDI-Public: 10653160382676
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: DYNDV2522A
• Device Lot Number: 2025082790
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2026
• 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: 02/05/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (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