Device Problems
Inaccurate Flow Rate (1249); Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that the grey top culture and sensitivity tube in the surestep foley urine sampling kit was not drawing urine into it and the other tubes in the kit were working fine.
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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.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 device was not returned.
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Event Description
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It was reported that the grey top culture and sensitivity tube in the surestep foley urine sampling kit was not drawing urine into it and the other tubes in the kit were working fine.
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Manufacturer Narrative
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He reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be ¿ error of inspector".The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.
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Search Alerts/Recalls
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