MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TOTAL JOINT PACK

Catalog Number	DYNJ23384L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on 6/5, "during procedure, a yankauer suction tip was observed to be broken by pa and surgical tech.It was stated that the item pieces were complete.After surgical tech was relieved, the yankauer was inspected by or nurse and relief tech.The yankauer was not intact ( a 2mmx3mm piece of plastic was not there) so md notified.
Additional Manufacturer Narrative
According to the facility on 6/5, "during procedure, a yankauer suction tip was observed to be broken by pa and surgical tech.It was stated that the item pieces were complete.After surgical tech was relieved, the yankauer was inspected by or nurse and relief tech.The yankauer was not intact ( a 2mmx3mm piece of plastic was not there) so md notified.Room was thoroughly searched.Patient's sutures were removed and surgical site was inspected, irrigated and sutured back up.Xray to be completed in pacu.Patient was reopened as described and completed wash out.Out.Pa further stated that there is a filter attached to the suction that is unable to be opened and there is a good chance that the plastic piece is in the filter".A 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.

• Common Device Name: TOTAL JOINT PACK
• 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: 19950500
• Report Number: 1423395-2024-00457
• Device Sequence Number: 15649745
• Product Code: OJH
• UDI-Device Identifier: 40193489259811
• UDI-Public: 40193489259811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/09/2024

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: DYNJ23384L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/09/2024
• 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 Age: 82 YR
• Patient Sex: Female