VACUETTE PLASTIC CANNULA HOLDEX STERILE
Received Nov 2, 2020
Report 8020040-2018-00024 · MDR key 10771010
Device
Generic name
Tube Holder
Manufacturer
Greiner Bio-one GmbhModel number
450216Catalog number
450216
Lot number
A18063GP
Product problems
- Physical Resistance/Sticking
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPLAINT (B)(4). RECEIVED 2 BAGS 450216/A18063GP 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 AFTER DRAWING THE SAMPLE, THE NEEDLE IS COMING OUT OF THE CANNULA AND GETTING STUCK IN THE SAMPLE TUBE CAP. THE HOLDEX HOLDER IS USED TO DRAW SAMPLES FROM A HAEMONETICS PLASMA BOTTLE SAMPLING PORT. GREINER TUBES ARE USED.