Model Number 806516 |
Device Problems
Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Hemorrhage/Bleeding (1888); Pain (1994); Patient Problem/Medical Problem (2688)
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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 patient stated the silicone catheters were too large and not pliable.He stated that they caused him pain and bleeding, which caused problems around the hole in his belly in his bladder.
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Manufacturer Narrative
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The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿outside diameter too large¿ with a potential root cause of ¿incorrect catheter buildup and/or finish dipping¿.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." 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 stated the silicone catheters were too large and not pliable.He stated that they caused him pain and bleeding, which caused problems around the hole in his belly in his bladder.
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Search Alerts/Recalls
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