MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER, IV, SURESITE AUTO, 22G X 1.00"

Catalog Number	DYNA22100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 the iv was placed and being flushed for a "colonoscopy" when "the catheter broke apart from the hub inside the patient".The customer reported "several nurses attempted to feel for the catheter but were not successful".The customer reported "911 was called" and the patient required a "venotomy" procedure for removal of the catheter.The customer reported the patient is stable and being monitored.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2024 the iv was placed and being flushed for a "colonoscopy" when "the catheter broke apart from the hub inside the patient".

• Common Device Name: CATHETER, IV, SURESITE AUTO, 22G X 1.00"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19311176
• Report Number: 1417592-2024-00600
• Device Sequence Number: 12466575
• Product Code: FOZ
• UDI-Device Identifier: 30193489140075
• UDI-Public: 30193489140075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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 Catalogue Number: DYNA22100
• Device Lot Number: 2782310002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/14/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown