SALTER LABS
Report
- Report Number
- 3000219639-2024-00108
- Event Type
- Malfunction
- Date Received
- October 16, 2024
- Report Date
- November 15, 2024
- Manufacturer
- SALTER LABS
- Product Code
- CCW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6 (G): (APPROPRIATE TERM/CODE NOT AVAILABLE): LARYNGOSCOPE BLADE. THE ACTUAL COMPLAINT PRODUCT 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 16 OCT 2024 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 COMPLAINT (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.
H6 (G): (APPROPRIATE TERM/CODE NOT AVAILABLE): LARYNGOSCOPE BLADE. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, A PHOTO/VIDEO OF THE REPORTED EVENT WAS PROVIDED. THE EVENT COULD BE CONFIRMED AS REPORTED; HOWEVER, THE ROOT CAUSE HAS NOT BEEN CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 15 NOV 2024 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 COMPLAINT (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.
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT DEPARTMENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3000219639-2024-00106 FOR THE FIRST REPORT. REFER TO 3000219639-2024-00107 FOR THE SECOND REPORT. IT WAS REPORTED, THE LIP AROUND THE OUTER EDGE OF THE LARYNGOSCOPE BLADE WHICH IMPEDED THE LINE OF SIGHT AND ALSO INTERFERED WITH THE MAGILL FORCEPS THAT WERE USED WHEN NASALLY INTUBATING A PATIENT; IT WAS ADDITIONALLY NOTED WHEN PASSING THE ENDOTRACHEAL TUBE (ETT) THE LIGHT WAS BLOCKED. THERE WAS NO REPORTED INJURY.
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT DEPARTMENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3000219639-2024-00106 FOR THE FIRST REPORT. REFER TO 3000219639-2024-00107 FOR THE SECOND REPORT. IT WAS REPORTED, THE LIP AROUND THE OUTER EDGE OF THE LARYNGOSCOPE BLADE WHICH IMPEDED THE LINE OF SIGHT AND ALSO INTERFERED WITH THE MAGILL FORCEPS THAT WERE USED WHEN NASALLY INTUBATING A PATIENT; IT WAS ADDITIONALLY NOTED WHEN PASSING THE ENDOTRACHEAL TUBE (ETT) THE LIGHT WAS BLOCKED. THERE WAS NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1287909 | SALTER LABS | UNKNOWN, SINGLE USE DISPOSABLE LARYNGOSCOPE BLADE | CCW | SALTER LABS | 1031.C | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |