MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. 7496 HFS MINI PLUS KIT; GENERAL SURGERY TRAY

Model Number DYNJ10210B

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2020

Event Type  malfunction  

Event Description

Upon counts, it was determined that the kit had six 18x18 x-ray lap sponges instead of the five.

• Brand Name: 7496 HFS MINI PLUS KIT
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9840483
• MDR Text Key: 183740982
• Report Number: 9840483
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ10210B
• Device Catalogue Number: DYNJ10210B
• Device Lot Number: 19KBF989
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1