MAUDE Adverse Event Report: MEDSOURCE LABS LLC MEDLINE; MEDLINE SURESITE SLIDE IV CATHETER

Model Number	DYNSCS22100
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
- customer returned unused product from the reported lot numbers to medsource for evaluation.- lot numbers were as follows: - dynscs22100 - lot: 27825060001.- dynscs20100 - lot: 27824100001.- dynscs20100 - lot: 27825010001.- dynscs20100 - lot: 27825060005.- dynscs24340 - lot: 27825060002.- dynscs24340 - lot: 27825010002.- medsource evaluated 50 samples of each reported lot number.- unused product was tested for: visual inspection & functional testing of the safety mechanism.- upon testing, no non-conformances were identified.- supplier conducted an investigation of the batch manufacturing records, supplier verification reports, and control samples.Full results of the investigation were sent to medsource.- batch manufacturing records: the batch manufacturing records (bmr) for each reported batch were reviewed.No non-conformities related to the complaint were observed.- supplier verification: the supplier verification reports were reviewed for any supplier or raw material changes.It was verified no changes were incorporated in the process or materials.- control samples: control samples for each reported lot were tested for: visual inspection, functional test - safety mechanism test & fitment (top cover & catheter body), and functional test - locking & unlocking force (in between gauge chamber 2 and needle hub).No non-conformities were observed.- no root cause found.- supplier provided these possible root causes: o manufacturing defect: - may be that an improper inspection was carried out by the quality inspector during the in-process and final inspection stage.- may be an improper assembly or misalignment (ex: safety slider not correctly aligned with locking feature).- may be that burrs, flash, or surface defects were present leading to sticking or incomplete travel of the slide.O user error: - may be due to mishandling of the product.- may be that the device was not handled according to the instruction for use.- may be attributed to the user not confirming proper engagement of the sliding safety mechanism, as indicated by the tactile/audible "click", during routine procedural use.Supplier's provided conclusion: based on the investigation and evaluation of control samples from each of the reported lots, no product non-conformities were identified.The safety mechanism was found to function as intended under standard test conditions, and the reported issue could not be reproduced.Based on available evidence and analysis, the complaint is considered likely to be use-related.The observed condition may be associated with handling practices or deviation from the instructions for use, particularly related to proper engagement of the sliding safety mechanism.
Event or Problem Description
Customer provided the description that "the safety feature does not always work".Customer provided multiple gauge sizes and lot numbers as possibly affected.The part numbers and lot numbers provided are as follows: dynscs22100 - lot: 27825060001 dynscs20100 - lot: 27824100001 dynscs20100 - lot: 27825010001 dynscs20100 - lot: 27825060005.Dynscs24340 - lot: 27825060002.Dynscs24340 - lot: 27825010002.

• Brand Name: MEDLINE
• Common Device Name: MEDLINE SURESITE SLIDE IV CATHETER
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby court; chanhassen MN 55317
• MDR Report Key: 25449210
• Report Number: 3003674698-2026-01222
• Device Sequence Number: 17583577
• Product Code: FOZ
• UDI-Device Identifier: 10888277667549
• UDI-Public: 10888277667549
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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 Model Number: DYNSCS22100
• Device Catalogue Number: DYNSCS22100
• Device Lot Number: 27825060001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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