BD E-Z SCRUB
Received Apr 20, 2023 · Event occurred Mar 7, 2023
Report 1710034-2023-00432 · MDR key 16780986
Device
Generic name
Bd E-z Scrub
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.Catalog number
372053
Lot number
2130571
Product problems
- Contamination
- Contamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, IT DOES APPEAR THAT THERE IS AN ORGANIC GROWTH ON THE OUTSIDE OF THE SHIPPERS FACING THE MIDDLE OF THE PALLET. NO OTHER PHOTOS WERE RECEIVED TO SHOW IF THE SHIPPERS FACING OUTWARD WERE AFFECT AND NO SAMPLES WERE RECEIVED TO CONFIRM IF THE GROWTH IS MOLD. THIRTY (30) RETAINED UNITS WERE VISUAL INSPECTED. NO MOLD OR FOREIGN MATTER WAS FOUND ON THE PACKAGE UNITS OR DISPENSER. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. THE ROOT CAUSE IS UNDETERMINED. THE INVESTIGATION DID NOT IDENTIFY CONCLUSIVE EVIDENCE OF WHERE OR HOW THE SHIPPERS CAME IN CONTACT WITH MOLD. A PROBABLE ROOT CAUSE COULD BE THE TEMPERATURE AND HUMIDITY OF THE AREA THE PRODUCT WAS SHIPPED TO. THE SHIPMENT IS DONE VIA BOAT IN A METAL SHIPPING CONTAINER. THERE ARE NO ENVIRONMENTAL CONTROLS IN THE CONTAINER TO PREVENT AGAINST CONDENSATION BUILD UP ON PRODUCT FROM THE INCREASED HUMIDITY OF THE AREA. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem
RECEIVED BY CUSTOMER WITH VISIBLE MOLD ON BD BOX.
Additional Manufacturer Narrative
(B)(4). INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.