Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits and any excursions above the control limits are assessed and documented as part of this monthly review.
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It was reported that a swan model d97130f5, lot 64555169, did not capture.A new catheter was used and had capture immediately.There was no allegation of patient injury noted.11/10/2022- ch update: information received with only one catheter complaint.The date of event was (b)(6) 2022.The event occurred during the case and a terumo 7f introducer was utilized.It was confirmed that there was no injury to the patient.11/10/2022- ch update.Information that the swan is unavailable for return.
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