STERILE SPECIMEN TRAP (40CC) * DYND 44000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-18 for STERILE SPECIMEN TRAP (40CC) * DYND 44000 manufactured by Medline Industries, Inc..

Event Text Entries

[18165118] Bronchoscopy was performed in intensive care unit at bedside. Procedure had been completed. Rn who assisted with the procedure had on gown, gloves, and mask. She had already removed fluid resistant face shield. Nurse was leaning over the specimen bottle when latex tubing spontaneously disconnected from the sputum trap (specimen bottle), sprung back and contents splashed the nurse in the right eye.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	214948
MDR Report Key	214948
Date Received	1999-03-18
Date of Report	1999-03-09
Date of Event	1999-02-21
Date Facility Aware	1999-02-21
Report Date	1999-03-10
Date Reported to FDA	1999-03-10
Date Reported to Mfgr	1999-03-10
Date Added to Maude	1999-03-22
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
Reporter Occupation	RISK MANAGER
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	STERILE SPECIMEN TRAP (40CC)
Generic Name	SPUTUM TRAP (SPECIMEN BOTTLE)
Product Code	BYZ
Date Received	1999-03-18
Model Number	*
Catalog Number	DYND 44000
Lot Number	8L1231
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	208514
Manufacturer	MEDLINE INDUSTRIES, INC.
Manufacturer Address	ONE MEDLINE PLACE MUNDELEIN IL 600604486 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	1999-03-18