* 406

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-10 for * 406 manufactured by Busse Hospital Disposables.

Event Text Entries

[19462128] The laboratory has recieved many of these containers that were not leaking from the screw containers but rather from the tubing section. In some cases, irretrievable specimens have been lost in transport as a result of the leakage. The laboratory has attempted a number of methods to better seal these containers in order to prevent specimen loss, but with have had minimal success.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1422231
• MDR Report Key: 1422231
• Date Received: 2009-07-10
• Date of Report: 2009-07-10
• Date of Event: 2009-07-02
• Report Date: 2009-07-10
• Date Reported to FDA: 2009-07-10
• Date Added to Maude: 2009-07-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: STERILE MUCUS SPECIMEN TRAPS
• Product Code: LIO
• Date Received: 2009-07-10
• Model Number: *
• Catalog Number: 406
• Lot Number: 0821027
• ID Number: *
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BUSSE HOSPITAL DISPOSABLES
• Manufacturer Address: P.O. BOX 11067 HAUPPAUGE NY 11788092 US 11788 0920

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-07-10