MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; THORACOTOMY

Model Number	DYNJ904147B
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	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 08/01/2022, 'an unidentified growth was found on the suction tubing which came in the sterile thoracotomy pack'.The growth was noticed by the physician's assistant, 'after the incision was made and the surgeon had started surgery'.Per the facility, 'the patient was started on prophylactic antibiotics, and the sterile field was tore down and a new kit was opened with a two person inspection of every item that came from the new kit prior to being placed on the new sterile field'.According to the facility, 'the patient is doing well and there are no reported effects from the event date'.A sample from the same lot was requested to be returned for evaluation.No additional information is available at this time.Due to the reported incident and 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 08/01/2022, 'an unidentified growth was found on the suction tubing which came in the sterile thoracotomy pack'.

• Brand Name: Medline Industries, Inc.
• Common Device Name: THORACOTOMY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15402319
• Report Number: 1423395-2022-00030
• Device Sequence Number: 5183771
• Product Code: LRO
• UDI-Device Identifier: 10195327047269
• UDI-Public: 10195327047269
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: DYNJ904147B
• Device Catalogue Number: DYNJ904147B
• Device Lot Number: 22BME571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 71 KG