Model Number FOL0100 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2022 |
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.
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Event Description
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It was reported that there were 2 incidents on april and may where the foley statlock did not stay clipped around the catheter tubing and stated that the nurse changed the statlock approximately every 4 weeks.Per investigator notification on (b)(6) 2022, stated that the customer returned 3 additional stabilization devices that were used.
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Event Description
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It was reported that there were 2 incidents on april and may where the foley statlock did not stay clipped around the catheter tubing and stated that the nurse changed the statlock approximately every 4 weeks.Per investigator notification on 23aug2022, stated that the customer returned 3 additional stabilization devices that were used.Per notification from investigator on 09sep2022, it was found that the clamp was disconnected from the swivel base during sample evaluation.
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Manufacturer Narrative
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The reported event was unconfirmed as the evaluated sample met specification.Although an exact root cause could not be determined a potential root cause could be inappropriate snap fit.The lot number was unknown; therefore, the device history record could not be reviewed.Labelling review was not required as the reported event was unconfirmed.H11: section a through f - 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.H3 other text : the actual/suspected device was inspected.
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Search Alerts/Recalls
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