MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; PATEWOOD MINOR PROCEDURE

Model Number DYNJ51729B

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, during a "left breast-needle localized excisional biopsy" the raytec was being used to "address bleeding" and frayed inside the patient.The customer reported "another instrument" was used to remove the frayed pieces but, no other follow up care was required related to the reported incident.The customer reported there was no serious injury related to the reported incident.No additional information is available at this time.The sample was requested 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.

Event Description

According to the customer, during a "left breast-needle localized excisional biopsy" the raytec was being used to "address bleeding" and frayed inside the patient.

• Brand Name: Medline Industries, Inc.
• Type of Device: PATEWOOD MINOR PROCEDURE
• 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: 17175096
• MDR Text Key: 317642150
• Report Number: 1423395-2023-00030
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10193489285161
• UDI-Public: 10193489285161
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNJ51729B
• Device Catalogue Number: DYNJ51729B
• Device Lot Number: 23CBD530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other