Device Problem
Increase in Suction (1604)
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Patient Problem
Abrasion (1689)
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Event Date 11/15/2023 |
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.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient got abrasion from using purewick female external catheter in hospital.Patient stated that they were using purewick urine collection system incorrectly and the suction was high.
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Event Description
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It was reported that the patient got abrasion from using purewick female external catheter in hospital.Patient stated that they were using purewick urine collection system incorrectly and the suction was high.
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Manufacturer Narrative
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The reported event is inconclusive as no sample was returned for evaluation.A potential root cause could be due to "dimensions not specified correctly".The dhr review could not be performed without a lot number.The product catalog number for this device is unknown.Therefore, bd 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.H3 other text : the device was not returned.
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Search Alerts/Recalls
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