Other, other text: no lot number was provided; therefore, device history record review could not be performed.Two product samples were received for evaluation.Visual and functional testing were performed.Visual inspection found tier damage due embedded resin in the circuit.Functional testing found the bag was inflated and successfully passed the test; however, the circuits did not pass, and leakage as failure mode reported was confirmed.The root cause of the reported issue was found to be the screw and barrel wear on flights, a condition that affects directly to the internal plastination process due worn flights on screw (injection moulding fault).An escalation was initiated on (b)(6) 2022 under an internal capa to replicate and confirm the potential causes identified through an internal ncr (opened in august).Current capa status ? implementation results.D4: device lot/serial number, udi number and g5 are unknown, no product information has been provided to date.
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