Device Problems
Deflation Problem (1149); Inflation Problem (1310); Device Fell (4014)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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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 a that a temperature sensing catheter fell out of the patient and was found lying on the bed after the patient returned from an x-ray.The balloon was intact.A new catheter was placed and a short time later, it was found on the bed with a deflated balloon.The facility tested the balloon and it deflated with minimal pressure.The balloon fluid emptied into the catheter and then into the bag.
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Manufacturer Narrative
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The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to ¿lumen compromised by puncture or cut¿ leading to a potential failure mode ¿lumen to lumen leakage¿ resulting in premature deflation and the catheter falling out.The lot number is unknown; therefore, the device history record could not be reviewed.The labeling review could not be performed because the product code and lot number for this catheter is unknown.Therefore, bd is unable to determine the associated labeling for review.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 a that a temperature sensing catheter fell out of the patient and was found lying on the bed after the patient returned from an x-ray.The balloon was intact.A new catheter was placed and a short time later, it was found on the bed with a deflated balloon.The facility tested the balloon and it deflated with minimal pressure.The balloon fluid emptied into the catheter and then into the bag.
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Search Alerts/Recalls
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