Model Number FOL0100 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2021 |
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 device was not returned.
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Event Description
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It was reported that the customer could not get the clamp on the foley statlock to stay closed.The representative looked at the package and confirmed that the patient was using fol0100 and had a 16 fr latex foley.The representative explained that fol0102 was for both silicone and latex foley¿s, while fol0100 was for silicone foley specifically.Per follow up on 12jul2021, the customer did not realize that it was not for a latex catheter.
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Event Description
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It was reported that the customer could not get the clamp on the foley statlock to stay closed.The representative looked at the package and confirmed that the patient was using fol0100 and had a 16 fr latex foley.The representative explained that fol0102 was for both silicone and latex foley¿s, while fol0100 was for silicone foley specifically.Per follow up on 12jul2021, the customer did not realize that it was not for a latex catheter.
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Manufacturer Narrative
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Per additional information received, it has been determined that this mdr event is not reportable.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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Search Alerts/Recalls
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