MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL, LLC. MEDLINE SURESITE IV AUTO SAFE IV CATHETER 22G XX 1.00"; Catheter, intravascular, therapeutic, short-term less than 30 days

Model Number	DYNA22100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not available to be returned.Medline sent the product to a third party for review.
Event or Problem Description
There was a reported incident where the catheter became disconnected from the hub.The iv nurse placed the catheter and connected the saline to the syringe to flush the line and the catheter disconnected from the hub.Ems was called due to nurses being unable to feel the catheter.

• Brand Name: MEDLINE SURESITE IV AUTO SAFE IV CATHETER 22G XX 1.00"
• Common Device Name: Catheter, intravascular, therapeutic, short-term less than 30 days
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL, LLC.; 8600 shelby ct; chanhassen MN 55317
• Manufacturer Contact: neeraj gupta ; 110-111 phase iv; udyog vihar sector 18; haryana, gurugram 12201-5 ; IN 122015
• MDR Report Key: 19202591
• Report Number: 3003674698-2024-00739
• Device Sequence Number: 8048347
• Product Code: FOZ
• UDI-Device Identifier: 10193489140071
• UDI-Public: 10193489140071
• Combination Product (Y/N): N
• 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): 04/29/2024

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: DYNA22100
• Device Catalogue Number: DYNA22100
• Device Lot Number: 27823100002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown