MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; TRAY,CHEST TUBE,STANDARD

Model Number	DYND07603
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that, during a chest tube procedure, the distal jaw of the peon component broke.The broken piece went into the patient and was required to be retrieved by the physician user.Despite multiple good faith attempts, the reporting facility was unable or unwilling to provide additional information.No adverse patient impact or further medical intervention and follow-up care was originally reported.A sample has not been received and a root cause for the reported incident has not been determined at this time.Due to the reported need for medical intervention to retrieve the broken peon jaw piece, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the distal jaw of the peon component broke.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: TRAY,CHEST TUBE,STANDARD
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12525989
• Report Number: 1038445-2021-00013
• Device Sequence Number: 3322778
• Product Code: LRO
• UDI-Device Identifier: 10884389257487
• UDI-Public: 10884389257487
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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 Model Number: DYND07603
• Device Catalogue Number: DYND07603
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention