FDA Adverse Event Other Summary report: N

SODIUM CHLORIDE INHALATION SOLUTION 7% 60 X 4 ML UNIT DOSE VIAL

MDR report key: 17632663 · Received August 25, 2023

Report

Report Number
MW5144983
Event Type
Other
Date Received
August 25, 2023
Manufacturer
PHARMACARIBE LLC
Product Code
CAF
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

(REPORTED DURING MONTHLY PSO CLIENT MEETING) WE ARE SEEING AN INCREASE IN NEAR MISS REPORTS RELATED TO CONFUSION BETWEEN 3% AND 7% SODIUM CHLORIDE NEBULIZER SOLUTIONS. INDIVIDUAL WRAPPED PACKAGING OPTIONS HAVE BEEN DIFFICULT TO OBTAIN; THEREFORE, THE HOSPITAL MUST PURCHASE BULK PACKAGING. WHEN AVAILABLE, INDIVIDUAL PACKAGE LABELS WERE EASY TO READ AND INCLUDED A BARCODE WHICH WAS USED BY RESPIRATORY STAFF DURING MEDICATION ADMINISTRATION. THE BULK SUPPLY INCLUDES NO BARCODE AND THE PRODUCT DESCRIPTION IS EXTREMELY DIFFICULT TO READ. TO MAINTAIN BCMA COMPLIANCE, PHARMACY STAFF NEED TO MANUALLY LABEL EACH VIAL (E.G., RESPULE) WITH A BARCODED LABEL. THE LABEL IS FLAGGED; HOWEVER, THERE IS RISK THAT THE LABEL MAY FALL OFF OR GET STUCK TO A DIFFERENT VIAL AS THE PLASTIC VIAL DOES NOT ALLOW FOR THE BEST LABEL ADHERENCE. INDIVIDUALLY LABELING EACH INHALATION VIAL IS VERY LABOR INTENSIVE FOR OUR LARGE INTEGRATED HEALTH NETWORK (8 TOTAL HOSPITALS; MAIN HOSPITAL IS 725 BEDS). CURRENT PRODUCT IS MANUFACTURED BY "PHARMACARIBE": ¿ SODIUM CHLORIDE 3% SOLUTION - NDC 50190-142-63 ¿ SODIUM CHLORIDE 7% SOLUTION - NDC 50190-141-23. IT'S HARD TO CAPTURE IN THE PICTURE, BUT ALL OF THE PRODUCT INFORMATION IS CAPTURED ON THE LONG TAB PORTION OF THE NEBULIZER PACKAGE. THE OTHER SIDE (NOT PICTURED) INCLUDES THE EXPIRATION DATE. EACH NEBULIZER MUST BE INDIVIDUALLY SEPARATED AND HAVE AN INDIVIDUAL BARCODE MANUALLY APPLIED PRIOR TO DISPENSING OR LOADING INTO AN AUTOMATED DISPENSING CABINET. ISMP IS A FEDERALLY CERTIFIED PATIENT SAFETY ORGANIZATION AND AN FDA MEDWATCH PARTNER. ISMP, 5200 BUTLER PIKE, PLYMOUTH MEETING, PA 19462; PHONE: 215-947-7797; EMAIL: [email protected]. SUBMISSION ID: (B)(4). REFERENCE REPORT: MW5144982.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
999566 SODIUM CHLORIDE INHALATION SOLUTION 7% 60 X 4 ML UNIT DOSE VIAL NEBULIZER (DIRECT PATIENT INTERFACE) CAF PHARMACARIBE LLC

Patients

Seq Age Sex Outcome Treatment
1 Unknown