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

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/25/2024

Event Type  Injury  

Manufacturer Narrative

The product was not available to be returned.Medline sent the product to a third party for review.

Event 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"
• Type of Device: 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
• MDR Text Key: 341281564
• Report Number: 3003674698-2024-00739
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10193489140071
• UDI-Public: 10193489140071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: DYNA22100
• Device Catalogue Number: DYNA22100
• Device Lot Number: 27823100002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization