MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MAJOR / O.R. MAJOR PACK; GENERAL SURGERY TRAY

Model Number DYNJ49354

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2021

Event Type  malfunction  

Event Description

Hand towel in major pack with excessive linking noted as the surgical technician was drying her hands in preparation for a surgical case.Fda safety report id# (b)(4).

• Brand Name: MAJOR / O.R. MAJOR PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 12008126
• MDR Text Key: 256792064
• Report Number: MW5101914
• Device Sequence Number: 1
• Product Code: LRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2021

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 Expiration Date: 10/31/2022
• Device Model Number: DYNJ49354
• Device Catalogue Number: DYNJ49354
• Device Lot Number: 21DBN858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR