MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE MICRO INST TRAY KONIG CARDINAL; TRAY, SURGICAL, INSTRUMENT

Model Number MDS0001038D

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Description

Date the person first started taking or using the product: (b)(6) 2021.Reason for use: trying to sterilize insert in it.Poor ifu; no date or revision.No mention on how to clear.No mention of pad inside."what other cycles? is a brand name and does non cover the various cycles it has.Please make them fix this.Unk of the two above.".

• Brand Name: MEDLINE MICRO INST TRAY KONIG CARDINAL
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 13252267
• MDR Text Key: 284108883
• Report Number: MW5106641
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/12/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: MDS0001038D
• Device Catalogue Number: MDS0001038D
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose