On (b)(6) 2012, salter labs vp ra/qa observed an adverse event reported via the maude database.
According to the maude event report, the 'input of the o2 portion" of a divided cannula "became loose and fell away¿causing the [patient] not to be hooked to the o2.
No harm came to the [patient], however, this was a concern".
Additionally, the event report states that "[salter labs] was contacted to notify company about this issue;" however, salter labs has no record of having received a complaint matching this description or lot number described in the event.
Once receiving notification via maude database, this complaint was formerly entered into the complaint handling system.
The (b)(6) was contacted to confirm it is not possible to determine the contact info for the initial reporting facility.
The (b)(6) confirmed initial reporter info is confidential.
Records for this par number, lot number, indicate that the lot of product in question went to a number of customers and an even larger number of customer locations.
Therefore, it is not possible to determine which customer/subsidiary customer likely filed the complaint and also not possible to determine the pt status or whether product can be returned for evaluation.
As the product in question has not been returned to salter labs for evaluation and there is no add'l product belonging to that part number, lot number in inventory for salter labs to perform an eval, it is not possible to confirm the failure and/or determine the root cause of the failure.
This is a final report.