SL CV FOR MAQUET IAB
Received Aug 13, 2021 · Event occurred Jul 19, 2021
Report 3006260740-2021-03322 · MDR key 12320973
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
0684000472
Lot number
JUFQ8517
Product problems
- Defective Component
- Defective Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED PACKAGE FOUND WITH THE PREP PAD OPEN. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED ON THREE DEVICES. THIS REPORT ADDRESS THE THIRD DEVICE.
Additional Manufacturer Narrative
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.
Additional Manufacturer Narrative
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUFQ8517 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUFQ8517) HAVE BEEN REPORTED FROM THE SAME FACILITY.
Description of Event or Problem
IT WAS REPORTED PACKAGE FOUND WITH THE PREP PAD OPEN. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED ON THREE DEVICES. THIS REPORT ADDRESS THE THIRD DEVICE.