MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MUCUS SPECIMEN TRAP 40 CC; TRAP, STERILE SPECIMEN

Catalog Number C30200A

Device Problem Device Packaging Compromised (2916)

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

Event Date 01/20/2016

Event Type  Injury  

Event Description

The respiratory staff found an insect inside the unopened sterile package.I have pictures if you wish.

• Brand Name: MUCUS SPECIMEN TRAP 40 CC
• Type of Device: TRAP, STERILE SPECIMEN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5477338
• MDR Text Key: 39597761
• Report Number: 5477338
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: C30200A
• Device Lot Number: 20150702_SH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1