AINTREE INTUBATION CATHETER
Received Feb 6, 2026 · Event occurred Feb 2, 2026
Report 1820334-2026-00129 · MDR key 24277507
Device
Product problems
- Device Contaminated During Manufacture or Shipping
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: BTR; TUBE, TRACHEAL (W/WO CONNECTOR). D2B - PRODUCT CODE: ADDITIONAL PRODUCT CODES: BTR. H3 - DEVICE EVALUATED BY MFG?: DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. AWAITING DEVICE RETURN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
Description of Event or Problem
IT WAS REPORTED THAT A HAIR-LIKE FIBER WAS FOUND WITHIN THE SEALED PACKAGING OF AN AINTREE INTUBATION CATHETER. THE DEVICE WAS NOT USED. NO HARM HAS BEEN REPORTED.