WHITACRE SET 25GA 3-1/2IN
Received May 6, 2025 · Event occurred Apr 17, 2025
Report 3003152976-2025-00198 · MDR key 21967989
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405076
Lot number
UNKNOWN
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.
Description of Event or Problem
WE HAVE RECEIVED THIS CUSTOMER QUERY REGARDING A BLUE SPOT ON THE PRODUCT (405075 AND 405076). THIS WAS DETECTED BEFORE USE ON A PATIENT, WHO DID NOT REPORT THAT THE PRODUCT HAD FAILED, BUT ASKED IF IT WAS NORMAL FOR IT TO HAVE THIS SPOT.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
(B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION: FOLLOWING A THOROUGH REVIEW BY OUR QUALITY TEAM, THE PHOTOS PROVIDED WERE ANALYZED AND DETERMINED NOT TO CORRESPOND WITH THE MATERIAL INFORMATION REPORTED. IT HAS BEEN CONFIRMED THAT THE PRODUCT SHOWN IN THE IMAGES IS NOT A BD-MANUFACTURED ITEM. BASED ON THE INFORMATION AVAILABLE, NO FAILURE HAS BEEN IDENTIFIED WITH ANY BD PRODUCT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.