Device Problem
Incorrect Measurement (1383)
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Patient Problem
Pain (1994)
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Event Date 05/26/2023 |
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 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 customer complained about the silicone drain bag foley tray with anti-reflux chamber, tamper-evident seal.There were 4 patients got hurt when they use foley catheter and also informed it was seemed thicker and customer were wondering if they changed the kit.No medical intervention was reported.
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Event Description
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It was reported that the customer complained about the silicone drain bag foley tray with anti-reflux chamber, tamper-evident seal.There were 4 patients got hurt when they use foley catheter and also informed it was seemed thicker and customer were wondering if they changed the kit.No medical intervention was reported.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "improperly molded or extruded / incorrect size selected".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The provided lot number was invalid therefore dhr review can¿t be completed.The product catalog number and the lot number for this device are 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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