MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CABG-PUMP-LF

Catalog Number	DYNJ76106C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 2/11 during a cabg, a "root cannula was placed into the aorta, surgeon was trying to screw off the top but wouldn't unscrew.Used 2 criles to unscrew the luer lock.Once free, attempted to withdraw the needle from cannula however the needle would not pass through due to a piece of plastic that was stuck in the cannula".The facility continued to state that the staff "removed the cannula from the aorta, sequestered on the sterile field to ensure all pieces were accounted for".Another aortic root cannula was opened in the field and used without any issues.There was a slight increase in length of surgery (about 5 minutes).The facility stated there was no harm to the patient and that the procedure was completed.The sample is not available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, 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 facility on 2/11 during a cabg, a "root cannula was placed into the aorta, surgeon was trying to screw off the top but wouldn't unscrew.Used 2 criles to unscrew the luer lock.Once free, attempted to withdraw the needle from cannula however the needle would not pass through due to a piece of plastic that was stuck in the cannula".

• Common Device Name: CABG-PUMP-LF
• 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: 21573766
• Report Number: 1423395-2025-00027
• Device Sequence Number: 20919607
• Product Code: OEZ
• UDI-Device Identifier: 10195327362591
• UDI-Public: 10195327362591
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/11/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: DYNJ76106C
• Device Lot Number: 24GDB342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/11/2025
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 64 KG