Model Number 0165SI14 |
Device Problem
No Flow (2991)
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Patient Problem
Urinary Retention (2119)
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Event Date 07/20/2017 |
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 no urine flowed after placement.
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Manufacturer Narrative
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The reported issue was unconfirmed.The device was returned and visual inspection noted no defects on the returned catheter.Evaluation observed no blockage in the drainage lumen.Water was introduced through the drainage eye and came out from drainage funnel without difficulty.The sample was sent for a flow rate test and passed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿contraindications method for use: do not reuse.Do not resterilize.Be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.]" (b)(4).
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Event Description
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It was reported that no urine flowed after placement.
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Search Alerts/Recalls
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