MAUDE Adverse Event Report: STATLAB MEDICAL PRODUCTS, INC. 10% NEUTRAL BUFFERED FORMALIN CONTAINER; DEVICE, SPECIMEN COLLECTION

Lot Number 29299

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

Unopened formalin container that was noted to have debris floating in it.Not opened and not used for any patient specimens.

• Brand Name: 10% NEUTRAL BUFFERED FORMALIN CONTAINER
• Type of Device: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): STATLAB MEDICAL PRODUCTS, INC.; 407 interchange street; mckinney TX 75071
• MDR Report Key: 3853100
• MDR Text Key: 4687202
• Report Number: 3853100
• Device Sequence Number: 1
• Product Code: HHT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: 29299
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1