MAUDE Adverse Event Report: MEDSOURCE LABS LLC MEDSOURCE; CLEARSAFE COMFORT 22G

Model Number	MS-84222
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Catheter detached and went into the vein.
Event or Problem Description
Catheter detached and went into the vein.
Additional Manufacturer Narrative
Medsource received an additional complaint for the same part number, lot number and issue (catheter shearing).The complaint was for an incident that occurred on (b)(6)2025.Medsource received the complaint from the distributor (linkpartners group, inc.) via (b)(6) on january 5, 2026.The affected sample was unable to be returned to medsource for further investigation.Because the affected sample could not be investigated, we are adding this instance to the mdr report for feedback 1080 as an investigation was performed under that complaint and it was for the same part number, and issue (catheter shearing).

• Brand Name: MEDSOURCE
• Common Device Name: CLEARSAFE COMFORT 22G
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct; chanhassen MN 55317
• MDR Report Key: 23949811
• Report Number: 3003674698-2025-01080
• Device Sequence Number: 13442982
• Product Code: FOZ
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K150611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MS-84222
• Device Catalogue Number: MS-84222
• Device Lot Number: 41340/0843
• Date Returned to Manufacturer: 08/22/2025
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown