MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MAJOR GENERAL SHARED

Catalog Number DYNJ64790B

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2024

Event Type  Injury  

Event Description

According to the customer, the reytec sponges were being used on 01/24/2024 for "hemostasis of the left neck dissection", and in the middle of the procedure the product was "coming apart in strings inside of the patient".

Manufacturer Narrative

According to the customer, the reytec sponges were being used on 01/24/2024 for "hemostasis of the left neck dissection", and in the middle of the procedure the product was "coming apart in strings inside of the patient".The customer reported the product was removed from the patient and removed from the surgical field after the reported incident occurred.The customer reported there was no serious injury, medical intervention/attention, or follow-up care needed related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.

• Type of Device: MAJOR GENERAL SHARED
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18759602
• MDR Text Key: 336010220
• Report Number: 1423395-2024-00048
• Device Sequence Number: 1
• Product Code: FDE
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ64790B
• Device Lot Number: 23JDA534
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other