BD E-Z SCRUB
Received Dec 30, 2020 · Event occurred Dec 3, 2020
Report 1710034-2020-00839 · MDR key 11097623
Device
Generic name
Chlorahexidine Gluconate Solution
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.Catalog number
371073
Lot number
9323782
Product problems
- Defective Device
- Defective Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. RETAIN SAMPLES WERE INSPECTED AND NOTHING WAS FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. COMPLAINTS ARE TRACKED AND TRENDED. H3 OTHER TEXT: SEE NARRATIVE BELOW.
Description of Event or Problem
IT WAS REPORTED THAT THERE IS A LACK OF CHLORHEXIDINE ON THE SPONGE.
Additional Manufacturer Narrative
(B)(4) INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THERE IS A LACK OF CHLORHEXIDINE ON THE SPONGE.