FDA Adverse Event Malfunction Summary report: N

BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB

MDR report key: 16811540 · Received April 25, 2023

Report

Report Number: 3012307300-2023-04553
Event Type: Malfunction
Date Received: April 25, 2023
Date of Event: March 21, 2023
Report Date: May 26, 2023
Manufacturer: SMITHS MEDICAL ASD, INC.
Product Code: JOH
UDI-DI: 15021312000719
PMA / PMN Number: K914088
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ONE SAMPLE DEVICE WAS RECEIVED IN UNUSED CONDITIONS WITH ITS ORIGINAL PACKAGING. THE DEVICE WAS FUNCTIONALLY TESTED, AND THE CUFF INFLATED SUCCESSFULLY. A REVIEW OF MANUFACTURING DEVICE HISTORY RECORDS FOUND NO CONFORMANCES FOR THE REPORTED LOT NUMBER. BASED ON THE AVAILABLE INFORMATION, THE COMPLAINT COULD NOT BE CONFIRMED IN THE SAMPLE DEVICE. NO ACTIONS HAVE BEEN TAKEN AT THIS TIME.

Additional Manufacturer Narrative · 0

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN REQUIRED.

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING THE PRE-USE TESTING THE TRACH BALLOON WOULD NOT INFLATE. IT WAS THOUGHT TO BE DEFECTIVE. THE SECOND DEVICE HAD THE SAME ISSUE. THE STAFF PULLED THE THIRD OFF THE SHELF, DUE TO SAME LOT NUMBER, AND REMOVED FROM STOCK UNOPENED. NO INJURY REPORTED. (CC-0192909 REPRESENTS THE FIRST ITEM. CC-0192936 REPRESENTS THE SECOND ITEM, CC-0192943 REPRESENTS THE THIRD ITEM.)

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1186446	BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB	TUBE TRACHEOSTOMY AND TUBE CUFF	JOH	SMITHS MEDICAL ASD, INC.	67SP035	3894891	15021312000719

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown