MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE MINOR PROCEDURE TRAY; GENERAL SURGERY TRAY

Model Number DYNJ51729B

Device Problems Material Fragmentation (1261); Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/19/2023

Event Type  malfunction  

Event Description

Raytec frayed and md (physician) had to pick a piece out of the patient's inguinal hernia incision.Raytec package was in the minor procedure pack.All 10 raytecs, that were originally in this pack, were removed from the sterile field and a package of new raytecs (from our supply room) was opened and used instead.Pt (patient) undergoing inguinal hernia repair.

• Brand Name: MEDLINE MINOR PROCEDURE TRAY
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD; northfield IL
• MDR Report Key: 17004321
• MDR Text Key: 316054750
• Report Number: MW5117861
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ51729B
• Device Catalogue Number: DYNJ51729B
• Device Lot Number: 23CBD530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American