FDA Adverse Event Malfunction Summary report: N

RT MASK INTUBATION ADAPTER

MDR report key: 171732 · Received June 8, 1998

Report

Report Number: 1423507-1998-00180
Event Type: Malfunction
Date Received: June 8, 1998
Report Date: June 8, 1998
Manufacturer: ALLEGIANCE HEALTHCARE
Product Code: BZA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

5/13/1998 UNFORTUNATELY WITHOUT SAMPLES, CUSTOMER REPORT COULD NOT BE CONFIRMED. HOWEVER, IF SAMPLES BECOME AVAILABLE, WE WILL BE GLAD TO REOPEN THIS INVESTIGATION. 6/2/1998 SAMPLE WAS RECEIVED OPENED AND IT WAS INCLUDED WITH AN INSERT LABEL. HOWEVER INFO MENTIONS THAT LABEL THAT IS INCLUDED IS FROM ANOTHER LOT WHICH MAY OR MAY NOT BE THE SAME AS AFFECTED UNIT. SAMPLE IS OCCLUDED MIDWAY BETWEEN TWO ENDS. CUSTOMER REPORT WAS CONIRMED. 11/18/1998 SAMPLE WAS RECEIVED AND WE INSPECTED VISUALLY. CUSTOMER REPORT WAS CONFIRMED. SAMPLE WAS FOUND TO BE OCCLUDED MIDWAY BETWEEN TWO ENDS. CORRECTIVE ACTIONS HAVE BEEN INITIATED BOTH BY OUR FACILITY, AS WELL AS MFG FACILITY WHERE THIS PRODUCT IS MOLDED TO ADDRESS THE COMPLAINT. MFG FACILITY LAUNCHED INTENSIVE INVESTIGATION INTO THIS MATTER AND HAS IDENTIFIED ROOT CAUSE RESPONSIBLE FOR THIS TYPE OF REPORT. IN ADDITION, ALLEGIANCE HEALTHCARE CORP INITIATED VOLUNTARY RECALL OF ALL PRODUCT POTENTIALLY AFFECTED BY ROOT CAUSE AND HAS NOTIFIED FDA OF THIS ACTION. ADDITIONAL CORRECTIVE ACTIONS, AT THE MFG FACILITY, HAVE ALSO BEEN INITIATED AND WERE IMPLEMENTED IN SEPTEMBER OF 1998.

Description of Event or Problem · 1

ACCOUNT STATES THE ADAPTER WAS FOUND TO BE COMPLETELY OCCLUDED BY A THIN FILM OF PLASTIC. THE ANOMOLY WAS FOUND DURING SETUP BEFORE ACTUAL PT USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RT MASK INTUBATION ADAPTER	ADAPTER	BZA	ALLEGIANCE HEALTHCARE	001820	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	*		Other