VACUETTE PLASTIC CANNULA HOLDEX STERILE
Received Nov 2, 2020
Report 8020040-2018-00025 · MDR key 10771008
Device
Generic name
Tube Holder
Manufacturer
Greiner Bio-one GmbhModel number
450216Catalog number
450216
Lot number
A18054UP
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPLAINT (B)(4). RECEIVED 15PCS 450261/A18054UP FOR EVALUATION. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND SAMPLES TO OUR AFFILIATED HEADQUARTERS IN (B)(4) FROM WHICH WE RECEIVE THIS PRODUCT. ACCORDING TO THEIR INVESTIGATION AND COMMENTS, A REVIEW OF PRODUCTION DOCUMENTATION OF THE CONCERNED MATERIAL/BATCH SHOWS NO IRREGULARITIES RELATED TO THE REPORTED ERROR. THE CUSTOMER RETURNED SAMPLES WERE VISUALLY CHECKED; NO DEVIATIONS WERE OBSERVED. SAMPLES WERE FUNCTIONALLY CHECKED; NO ABNORMALITIES WERE DETECTED. IN ADDITION, THE TENSILE STRENGTH TEST DID NOT REVEAL ANY DEVIATIONS. THE COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem
CUSTOMER STATES THE NEEDLE BROKE UPON INSERTION OF THE TUBE.