BROSELOW TAPE VERSION 3
Received Dec 18, 2025 · Event occurred Dec 5, 2025
Report 23837390 · MDR key 23837390
Device
Generic name
Emergency Response Safety Kit
Manufacturer
Sunmed Group Holdings, Llc Dba AirlifeModel number
AE-4800Catalog number
AE-4800
Lot number
ALL
Product problems
- Application Program Problem: Dose Calculation Error
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
S [SITUATION]: 2025 VERSION 3 BROSELOW TAPE HAS BEEN IDENTIFIED TO INCLUDE 2 INCORRECT MEDICATION DOSAGES LISTED IN THE CALCULATION LEGEND. B [BACKGROUND]: BROSELOW TAPE IS A TOOL USED IN PEDIATRIC EMERGENCIES TO HELP DOSE MEDICATIONS AND SELECT APPROPRIATELY SIZED EQUIPMENT. A NEW VERSION WAS RELEASED IN 2025. A [ASSESSMENT]: IT HAS BEEN IDENTIFIED THAT THERE ARE 2 MEDICATIONS WITH INCORRECT DOSAGES LISTED ON THE "CALCULATED BASIS" PORTION OF THE TOOL AFFECTING THE LISTED VECURONIUM AND FLUMAZENIL. THE PRECALCULATED DOSAGES ARE LISTED CORRECTLY IN THE COLOR-CODED PORTION. R [RECOMMENDATION]: NOTIFICATION OF ALL KEY STAKEHOLDERS AND WIDESPREAD AWARENESS OF ISSUE, BLACK OUT THE INCORRECT INFORMATION ON ALL VERSION 3 BROSELOW TAPES IN CIRCULATION AT [REDACTED], [REDACTED], AND [REDACTED] HEALTH CENTER, AND REPLACEMENT WITH CORRECTED BROSELOW TAPE ONCE IT BECOMES AVAILABLE FROM THE MANUFACTURER. THIS IS SIMILAR TO THE ISSUE THE MANUFACTURER REPORTED IN A BULLETIN ABOUT THE PREVIOUS VERSION (VERSION 2) IN MAY 2025. SUPPLY CHAIN EMAILED THE VENDOR REP MULTIPLE TIMES IN THE PAST WEEK TO ASK FOR AN UPDATE AND DOCUMENTATION ABOUT THESE ERRORS AND HAVE NOT RECEIVED ANY RESPONSES. MANUFACTURER RESPONSE FOR MEDICATION CALCULATION GUIDANCE DOCUMENT, BROSELOW TAPE VERSION 3 (PER SITE REPORTER). SEVERAL ATTEMPTS TO REACH VENDOR WITHOUT REPLIES.