Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2021 |
Event Type
malfunction
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Event Description
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It was reported that the patient got 3 of the bard statlocks from another supplier and were defective.No additional or more specific information was provided, and the patient wanted to speak with the manufacturer about this issue.Per follow-up via phone on 22nov2021, patient had another statlock that would not stay closed and just pop opened.This made a total of 6 statlocks out of 12.The patient was very upset because they were unable to reach someone that could assist with a replacement for the broken statlocks.
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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 device was not returned.
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Event Description
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It was reported that the patient got 3 of the bard statlocks from another supplier and were defective.No additional or more specific information was provided, and the patient wanted to speak with the manufacturer about this issue.Per follow-up via phone on 22nov2021, patient had another statlock that would not stay closed and just pop opened.This made a total of 6 statlocks out of 12.The patient was very upset because they were unable to reach someone that could assist with a replacement for the broken statlocks.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be due to ¿inappropriate snap fit¿.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number is unknown.Therefore, bard is unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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 bd.
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Search Alerts/Recalls
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