MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE,BULB,TRAY,STER,CE

Catalog Number	DYNDE20125
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, "a male patient was treated in the operating theatre on (b)(6) 2024 for an aortic valve replacement using a mini-sternotomy.The patient was discharged on (b)(6) 2024.On (b)(6) 2024, the patient complained of a painful right leg.On examination, no foot pulses were palpable in either foot.On (b)(6) 2024, the patient was taken to the operating theatre for an open embolectomy of the femoral artery.The embolus was removed; the embolus was the syringe cap of the bulb irrigation syringe that was used for the aortic valve replacement on (b)(6) 2024.This bulb syringe is an individually packaged item containing a plastic cap that is not part of the surgical equipment.All other items that were part of the surgical count were recorded and confirmed as correct in the surgical safety checklist.The device was not operated on but was a retained item from a previous operation".It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, 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, "a male patient was treated in the operating theatre on (b)(6) 2024 for an aortic valve replacement using a mini-sternotomy.The patient was discharged on (b)(6) 2024.On (b)(6) 2024, the patient complained of a painful right leg.".

• Common Device Name: SYRINGE,BULB,TRAY,STER,CE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19234025
• Report Number: 1417592-2024-00563
• Device Sequence Number: 6882684
• Product Code: KYZ
• UDI-Device Identifier: 40884389102313
• UDI-Public: 40884389102313
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/02/2024

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 Catalogue Number: DYNDE20125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 05/02/2024
• 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