Catalog Number FOL0101 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that the statlock popped open.
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Manufacturer Narrative
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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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Event Description
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It was reported that the statlock popped open.
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Manufacturer Narrative
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Received 1 unopened statlock catheter stabilization device only.The reported issue was unconfirmed, as the problem could not be reproduced.The returned sample was an unused part.It was proceed to open the pouch and taking out the device confirming that all components were present per specification fol0101 (one pad with its retainer and 2 skin preps).The pad with its retainer was visually inspected with no obvious defects found.In order to evaluate the functionality of the returned sample, the retainer was closed and opened several times with no issues found.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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Event Description
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It was reported that the statlock popped open.
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Search Alerts/Recalls
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