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Model Number 0043610 |
Device Problem
Suction Failure (4039)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that the negative pressure was applied to the wound suction, but the pressure was different from the usual pressure and so it was replaced.It was stated that replacing only the drain bag was normal and it seemed that the catheter product was defective.Per follow up via ibc on 19apr2022, the issue was about the catheter.Per follow up via ibc on 20apr2022, it was unknown whether the patient had injury or not.
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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.
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Event Description
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It was reported that the negative pressure was applied to the wound suction, but the pressure was different from the usual pressure and so it was replaced.It was stated that replacing only the drain bag was normal and it seemed that the catheter product was defective.Per follow up via ibc on (b)(6) 2022, the issue was about the catheter.Per follow up via ibc on (b)(6) 2022, it was unknown whether the patient had injury or not.
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Manufacturer Narrative
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The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for patient treatment.The product had not caused the reported failure.The device history record review was not required as the reported event was unconfirmed.A labeling review is not required as the reported event was unconfirmed.Correction: d, g, h 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 actual/suspected device was inspected.
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Search Alerts/Recalls
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