SUNMED LLC
Report
- Report Number
- 1314417-2023-00003
- Event Type
- Injury
- Date Received
- January 27, 2023
- Date of Event
- December 30, 2022
- Report Date
- January 27, 2023
- Manufacturer
- SUNMED HOLDINGS LLC
- Product Code
- CAE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 501
Narratives
MCKESSON LARYNGEAL MASK IS USED IN ACHIEVING AND MAINTAINING CONTROL OF THE AIRWAY DURING ROUTINE AND EMERGENCY ANESTHETIC PROCEDURES IN FASTED PATIENTS. DURING THE PROCEDURE, THE AIRWAY TUBE IS CAUSING SOFT TISSUE INJURY TO PATIENTS. COMPLAINT CONFIRMED WITH PHOTO. REVIEWED THE COMPLAINT HISTORY FOR THE 24 MONTHS PRECEDING THE COMPLAINT REPORTING DATE. THERE WERE ONLY 2 COMPLAINTS FOR THE PARTS LISTED IN THE COMPLAINT IN THAT TIMEFRAME. DISCUSSED WITH CLINICAL SUBJECT MATTER EXPERT AND DETERMINED THE MOST LIKELY ROOT CAUSE OF CLINICIAN USER ERROR. VISUALLY INSPECTED SIMILAR PART 159-001 INVENTORY AND NO NON-CONFORMANCES WERE FOUND. PERFORMED RISK ANALYSIS WITH (B)(6) AND DETERMINED A SEVERITY RATING OF 7/10. SENT RESOLUTION TO THE CUSTOMER.
MCKESSON LARYNGEAL MASK IS USED IN ACHIEVING AND MAINTAINING CONTROL OF THE AIRWAY DURING ROUTINE AND EMERGENCY ANESTHETIC PROCEDURES IN FASTED PATIENTS. DURING THE PROCEDURE, THE AIRWAY TUBE IS CAUSING SOFT TISSUE INJURY TO PATIENTS.
CAUSING SOFT TISSUE INJURIES TO PATIENTS.
CAUSING SOFT TISSUE INJURIES TO PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401163 | SUNMED LLC | MCKESSON LARYNGEAL MASK - PVC DISPOSABLE, SIZE 3, 4, 5, | CAE | SUNMED HOLDINGS LLC | 159-003, 004, 005 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |