MalfunctionLNZ
PORTEX ENDOTRACHEAL TUBE
Received Mar 30, 2022
Report 3012307300-2022-05561 · MDR key 13956067
Device
Generic name
Changer, Tube, Endotracheal
Manufacturer
Smiths Medical International, Ltd.Catalog number
100/150/075
Lot number
19092775
Product problems
- Loose or Intermittent Connection
- Loose or Intermittent Connection
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CUFF IS LOOSE. NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#(B)(4). A PRODUCT SAMPLE WAS RECEIVED AND SENT TO THE SUPPLIER FOR INVESTIGATION/EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS NEEDED ONCE THE INVESTIGATION RESULTS ARE PROVIDED.