FDA Adverse Event Malfunction Summary report: N

BIVONA

MDR report key: 25276773 · Received May 26, 2026

Report

Report Number
25276773
Event Type
Malfunction
Date Received
May 26, 2026
Date of Event
March 10, 2026
Report Date
May 14, 2026
Manufacturer
ICU MEDICAL, INC.
Product Code
JOH
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CT
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

S [SITUATION]: THREE NEO 3.0 TRACH TTS LOT NUMBER 6028880 MANUFACTURER DATE 6/24/2024; EXP DATE 6/23/2029 DEFECTIVE, REF 67SN030 NEW OUT OF THE BOX. B [BACKGROUND]: THE ROUTINE TRACH REMOVAL AND INSERTION CHECKLIST AND PROCEDURE IS REMOVED WITH EVERY NEW HIRE IN THE UNIT. A [ASSESSMENT]: DURING TEACHING A NEW HIRE, I GRABBED ABOVE TRACH (NEW PACKAGE-NEVER OPENED) TO SIM TRACH CUFF BALLOON CHECK. DURING THE BALLOON CHECK, THE BALLOON DID NOT INFLATE. I TRIED IT SEVERAL TIMES AND I HAD AN EXPERIENCED NURSE I WAS ONBOARDING ALSO CHECK IT. I THEN WENT AND GRABBED ANOTHER TRACH- SAME LOT NUMBER NEW OUT OF PACKAGE -- AND AGAIN THE CUFF WOULD NOT INFLATE. I BROUGHT TO [REDACTED] AND SHE TOO TRIED AND WAS UNABLE TO INFLATE BALLOON. ONE OF THE TRACHS EVENTUALLY HAD A SLIGHT INFLATION AND THEN IT ENDED UP INFLATING USING 5 CC SYRINGE. R [RECOMMENDATION]: I PULLED BOTH TRACHS AND MARKED DEFECTIVE AND ENTERED A SAFER. WE SHOULD PULL ALL NEO 3.0 TRACH TTS LOT NUMBER 6028880 MANUFACTURER DATE 6/24/2024; EXP DATE 6/23/2029 REF 67SN030. [REDACTED] ORDERED 3 MORE VIA RSS TO REPLACE THE ONES THAT WERE DEFECTIVE. ADDENDUM: FOUND 2 MORE SO I TESTED THEM. ONE INFLATED PROPERLY, THE OTHER ONE ONLY PARTIALLY INFLATED. I HAVE 4 BOXES OF NEW TRACHS TO RETURN. MANUFACTURER RESPONSE FOR ENDOTRACHEAL TUBE, NEO 3.0 TRACH TTS (PER SITE REPORTER).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
244822 BIVONA TUBE TRACHEOSTOMY AND TUBE CUFF JOH ICU MEDICAL, INC. 67SN030 6028880

Patients

Seq Age Sex Outcome Treatment
1