SALTER LABS
Report
- Report Number
- 3000219639-2022-00031
- Event Type
- Injury
- Date Received
- June 23, 2022
- Date of Event
- May 24, 2022
- Report Date
- June 23, 2022
- Manufacturer
- SALTER LABS
- Product Code
- CAT
- UDI-DI
- 10607411915779
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
IRRITATION/SORES CAN BE MANIFESTED BY ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER RESPIRATORY CARE PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES FOR SEVERAL REASONS, INCLUDING, THE DEVICE HAS BEEN CONTAMINATED WITH AN EXTERNAL SUBSTANCE (E.G., MOLD RELEASE AGENT, LOTIONS, MEDICATIONS) WHICH CAUSE IRRITATION/SORES, USING DEVICE FOR TOO LONG (MAY BECOME ROUGH OR BACTERIALLY CONTAMINATED), OR INDIVIDUAL PATIENT-SPECIFIC HYPERSENSITIVITY. IF THE OXYGEN TUBING IS NOT CHANGED OUT ON A REGULAR BASIS OR AS INDICATED ON THE PACKAGING SORES OR IRRITATIONS MAY RESULT. AS THE PATIENT DEVELOPED BURNS THIS IS REPORTABLE.
IRRITATION/SORES CAN BE MANIFESTED BY ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER RESPIRATORY CARE PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES FOR SEVERAL REASONS, INCLUDING, THE DEVICE HAS BEEN CONTAMINATED WITH AN EXTERNAL SUBSTANCE (E.G., MOLD RELEASE AGENT, LOTIONS, MEDICATIONS) WHICH CAUSE IRRITATION/SORES, USING DEVICE FOR TOO LONG (MAY BECOME ROUGH OR BACTERIALLY CONTAMINATED), OR INDIVIDUAL PATIENT-SPECIFIC HYPERSENSITIVITY. IF THE OXYGEN TUBING IS NOT CHANGED OUT ON A REGULAR BASIS OR AS INDICATED ON THE PACKAGING SORES OR IRRITATIONS MAY RESULT. AS THE PATIENT DEVELOPED BURNS THIS IS REPORTABLE. A REVIEW OF COMPLAINTS SUBMITTED OVER THE PREVIOUS 24 MONTHS WAS CONDUCTED FOR PRODUCT GROUP: "9-O2 CANNULA" USING THE SEARCH TERMS "RASH" (4), "IRRITATION" (4), "ALLERG" (4) AND OUT OF THAT TOTAL ONLY 3 OF THOSE COMPLAINTS ARE RELATED TO USE OF THE 16SOFT-7-50. THIS ISSUE DOES NOT APPEAR TO BE TRENDING BASED ON OVERALL SALES AND AN OVERALL 12M CPM TREND THAT IS SHOWING A DOWNWARD TREND. AN INVENTORY SEARCH WAS CONDUCTED AND NO INVENTORY OF THIS LOT # REMAINS IN STOCK. PRODUCT HAS NOT BEEN RETURNED FROM THE CUSTOMER AND THE COMPLAINT IS OVER 30 DAYS OLD SO THE COMPLAINT COULD NOT BE CONFIRMED. DHRS WERE REVIEWED FOR THE COMPONENT PIECES USED IN THIS PRODUCTION. ALL RECORDS INDICATE THE APPROPRIATE MATERIALS WERE USED IN PRODCUTION AND THE IN PROCESS AND QUALITY CHECKS PERFORMED WERE COMPLETED AND DID NOT INDICATE NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THIS COMPLAINT. CALLED THE POINT OF CONTACT IN THE COMPLAINT AND SHE STATED SHE IS ALLERGIC TO A LOT OF THINGS. I SHARED THE MATERIAL OF CONSTRUCTION IN THE CANNULA AND THAT IT IS TESTED FOR IRRITATION AND SENSITIVITY. THE MOST LIKELY ROOT CAUSE IS PATIENT HYPERSENSITIVITY TO THE CANNULA MATERIAL. RMA-20017A REV 2: R3 INDICATES THAT PATIENT EXPOSURE TO SKIN IRRITANT IS A EXTREME (7/10) SEVERITY AND DOES NOT MEET THE THRESHOLD FOR CARB REVIEW.
CUSTOMER IS ALLERGIC TO CANNULA. CANNULA HAS BURNED CUSTOMERS FACE, EYE BROWS, BACK OF NECK AND EARS.
CUSTOMER IS ALLERGIC TO CANNULA. CANNULA HAS BURNED CUSTOMERS FACE, EYE BROWS, BACK OF NECK AND EARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2473248 | SALTER LABS | ADULT NASAL CANNULA WITH 7' 3-CHANNEL TUBE - 50/CS | CAT | SALTER LABS | 16SOFT-7-50 | (10)220223J | 10607411915779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |