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Model Number 000792 |
Device Problems
Fracture (1260); Failure to Advance (2524); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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Event Description
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It was reported that during the feeding tube placement, the device allegedly unable to advance.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review:a lot history review, a device history record review, and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary:the device was not returned for evaluation.Therefore, the reported failure to advance and sheath damage issues cannot be confirmed.A definitive root cause could not be determined based upon available information.Labeling review:a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.
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Event Description
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It was reported that during the feeding tube placement, the device allegedly unable to advance.It was further reported that the device rips, shears and not long enough.There was no reported patient injury.
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Search Alerts/Recalls
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