BD WHITACRE NEEDLE
Received May 23, 2025 · Event occurred Mar 7, 2025
Report 9610048-2025-00072 · MDR key 22080398
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton Dickinson Industrias Cirurgicas, Ltda.Catalog number
408394
Lot number
UNKNOWN
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AS A LOT NUMBER WAS UNKNOWN FOR THIS INCIDENT, WE WERE UNABLE TO COMPLETE A PRODUCTION HISTORY REVIEW AND UNABLE TO IDENTIFY IF ANY PREVIOUS REPORTS HAVE BEEN RECEIVED FOR THE AFFECTED LOT REGARDING THIS TYPE OF DEFECT. WITHOUT THE PHYSICAL SAMPLE, OUR QUALITY TEAM WAS NOT ABLE TO COMPLETE A THOROUGH ANALYSIS. BASED ON THE LIMITED INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT OR LOT INVOLVED IN THIS INCIDENT MAY PROVIDE CLARIFICATION FOR THE CAUSE OF THIS REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND DEFECT WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT BD WHITACRE NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIQUID IS RUPTURING AND LEAKING FROM THE NEEDLE. WAS THERE ANY HARM TO THE PATIENT/HEALTH PROFESSIONAL? NO. DATE OF OCCURRENCE OF THE EVENT ON (B)(6) 2025?
Additional Manufacturer Narrative
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.