SALTER, CANNULAIDE
Report
- Report Number
- 3000219639-2025-00014
- Event Type
- Injury
- Date Received
- February 6, 2025
- Report Date
- September 29, 2025
- Manufacturer
- SALTER LABS DE MEXICO DE S.A. DE C.V.
- Product Code
- BZD
- PMA / PMN Number
- K143700
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 117
Narratives
THE ACTUAL SAMPLE, FROM THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
CORRECTION: D3; G1; H6. ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: D4; H2; H6. EVALUATION OF THE RETURNED SAMPLE CONFIRMED THE EVENT AS REPORTED. THE ROOT CAUSE WAS NOT DETERMINED; THE FAILURE MODE IS UNDER REVIEW. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 29 SEP 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3000219639-2025-00013 FOR THE FIRST REPORT. REFER TO 3000219639-2025-00015 FOR THE THIRD REPORT. REFER TO 3000219639-2025-00016 FOR THE FOURTH REPORT. IT WAS REPORTED THE BABY HAD A BREAKDOWN ON [THE SKIN ON] THEIR CHEEKS (SKIN IRRITATION AND REDNESS) DUE TO THE CANNULAIDE STICKING TO THEIR CHEEKS. IT WAS ADDITIONALLY REPORTED THE BABY EXPERIENCED A LOSS OF CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) AND LUNG VOLUME. THE CANNULAIDE HAD TO BE CHANGED.
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3000219639-2025-00013 FOR THE FIRST REPORT. REFER TO 3000219639-2025-00015 FOR THE THIRD REPORT. REFER TO 3000219639-2025-00016 FOR THE FOURTH REPORT. IT WAS REPORTED THE BABY HAD A BREAKDOWN ON [THE SKIN ON] THEIR CHEEKS (SKIN IRRITATION AND REDNESS) DUE TO THE CANNULAIDE STICKING TO THEIR CHEEKS. IT WAS ADDITIONALLY REPORTED THE BABY EXPERIENCED A LOSS OF CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) AND LUNG VOLUME. THE CANNULAIDE HAD TO BE CHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1247400 | SALTER, CANNULAIDE | CANNULAIDE | BZD | SALTER LABS DE MEXICO DE S.A. DE C.V. | CA101-0-25 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |