MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD SPECIMEN TRAP 80CC; TRAP, STERILE SPECIMEN

Lot Number 55822040021

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 05/08/2023

Event Type  Injury  

Event Description

The specimen container was received at lab with the lid off and the entire specimen was spilled into the bag requiring repeat bronchoscopy.

• Brand Name: SPECIMEN TRAP 80CC
• Type of Device: TRAP, STERILE SPECIMEN
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 16940751
• MDR Text Key: 315388413
• Report Number: MW5117570
• Device Sequence Number: 1
• Product Code: BYZ
• Combination Product (y/n): N
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 55822040021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White