MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; YANKAUER,POOLE TIP,STERILE,50/CS

Catalog Number	DYND50180
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that "device dislodged from suction catheter and remained in patient's abdominal cavity".It was reported about a week later, "the retained object was identified on radiologic imaging approx.2 weeks after dislodgement.The patient underwent a second surgery for removal.Device was removed without complication/ serious injury".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
Device dislodged from suction catheter and remained in patient's abdominal cavity.

• Common Device Name: YANKAUER,POOLE TIP,STERILE,50/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19070944
• Report Number: 1417592-2024-00472
• Device Sequence Number: 6900778
• Product Code: JOL
• UDI-Device Identifier: 40080196035084
• UDI-Public: 40080196035084
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/09/2024

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: DYND50180
• Device Lot Number: 48623030001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/09/2024
• 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: 18 YR
• Patient Sex: Male