MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-PICC LINE DOUBLE LUMEN CDS

Catalog Number	CDS982858F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the catheter in this kit was bent and would not reform and could not be used".
Additional Manufacturer Narrative
The account reported finding damaged component, and the complaint stated that the catheter was bent and would not reform and could not be used.Medline received 3 photos and observed a small kink along one side of the catheter line; finished good production records, finished good pack build, and trending were reviewed, and a sample was later received of a single catheter with small kink along the line.The reported issue was confirmed, and findings were not altered after the sample was received.Based on the component's location in the pack it is unlikely that placement contributed to the reported issue; the item was either damaged prior to placement in the pack and was not noted during assembly or the item became damaged due to rough handling of the pack, and the complaint was provided to the vendor for further evaluation.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-PICC LINE DOUBLE LUMEN CDS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50932806
• Report Number: 1417592-2026-52920
• Device Sequence Number: 16142214
• Product Code: LRO
• UDI-Device Identifier: 40888277739216
• UDI-Public: 40888277739216
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/27/2026

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: CDS982858F
• Device Lot Number: 23FMJ286
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/25/2024
• 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: 12/12/2023
• Initial Report FDA Received Date: 09/29/2026
• 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