MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; PQ BIOPSY PACK

Model Number	SPEC0240
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient was undergoing a computerized tomography (ct) guided bone marrow biopsy and aspiration and at the start of the procedure, when the interventional radiologist placed the hemostat in the patients skin to open and stretch the skin, a piece of the hemostat broke off in the patients skin.The radiologist was able to remove the piece of the hemostat safely (process of removal not reported) and there was no further impact or injury noted.The procedure was able to be completed with a new device.The sample was returned for evaluation and the customer reported issue was confirmed.The jaw tip was noted to be cleanly broken off of the hemostat with no additional physical defect or abnormality noted to the hemostat received.A definitive root cause could not be determined at this time.No additional information is available.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
It was reported that a patient was undergoing a procedure and a piece of the hemostat broke off in the patient's skin.The piece of the hemostat was safely removed (process of removal not reported) and there was no further impact noted.

• Brand Name: Medline
• Common Device Name: PQ BIOPSY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12967474
• Report Number: 1423395-2021-00060
• Device Sequence Number: 19966870
• Product Code: OFG
• UDI-Device Identifier: 10888277524897
• UDI-Public: 10888277524897
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SPEC0240
• Device Catalogue Number: SPEC0240
• Device Lot Number: 21HBN753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 79 YR
• Patient Sex: Unknown
• Patient Weight: 67 KG