The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
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Received 1 used statlock with the original unit packaging.The reported issue was unconfirmed, as the problem could not be reproduced.The returned sample was visually inspected observing that was attached to the internal wall of the pouch.There were no obvious defects detected on the pad and retainer of the sample.The pad has hair on the glue.As part of the functional testing the retainer was opened and closed in several times with no issues detected or anomalies associated with the reported complaint.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "warnings and precautions: do not use the statlock® device where loss of adherence could occur, such as with a confused patient, diaphoretic or nonadherent skin, or when the access device is not monitored daily.Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the statlock® device.Minimize catheter manipulation during application and removal of the statlock® device." the information provided by bard 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 bard.
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