MAUDE Adverse Event Report: SCIENTIFIC DEVICE LABORATORY, INC.; EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED FOR A SPECIFIC MEDICAL USE

Catalog Number 050-S

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

Glass slides packed by scientific device - unable to be removed from package in a sterile manner d/t package tearing, slides sticking to the packaging, and slides having a residual sticky, white substance on them after removal.Manufacturer: scientific device, item: sterile slide frosted end, reference: #050-s, lot: 042122.

• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED FOR A SPECIFIC MEDICAL USE
• Manufacturer (Section D): SCIENTIFIC DEVICE LABORATORY, INC.; 411 east jarvis; des plaines IL 60018
• MDR Report Key: 14547171
• MDR Text Key: 292995723
• Report Number: 14547171
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/16/2022,04/12/2022

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 Catalogue Number: 050-S
• Device Lot Number: 042122
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2022
• Date Report to Manufacturer: 05/31/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1