MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 2.6F X 50CM DL PICC MST STD

Catalog Number	PICC2650MST
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stylet has been difficult to remove after catheter is placed in the patient.The stylet comes preloaded in the catheter and appears undamaged upon opening the kit.
Additional Manufacturer Narrative
According to the facility, "the stylet is getting stuck in catheter when trying to remove it after inserting in the patient," and the facility reported "the picc team was able to remove the stylet and the picc remained in the patient; however, the event prolonged operating room time and sedation for the patient while they were trying to get the stylet removed." per the facility, no follow up care, medical, or surgical intervention or treatment was required.A sample was received for investigation; 17ea unused samples were received for evaluation, no resistance was noted when removing the stylet from any of the samples, and finished good production records found no nonconformances noted by production or qc personnel during first article, in-process, or case packaging inspections.Based on the complaint details, sample evaluation, and investigation, the complaint is not confirmed; no defects were observed when evaluating the returned samples, the complaint cannot be determined, and a root cause could not be determined.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: 2.6F X 50CM DL PICC MST STD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897026
• Report Number: 1417592-2026-50795
• Device Sequence Number: 5853006
• Product Code: LRO
• UDI-Device Identifier: 10653160385875
• UDI-Public: 10653160385875
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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: PICC2650MST
• Device Lot Number: 2025112190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2026
• 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: 03/12/2026
• Initial Report FDA Received Date: 09/25/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown