Model Number 175816 |
Device Problems
Burst Container or Vessel (1074); Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/21/2020 |
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 foley catheter with a 5 ml balloon was overinflated in a patient's bladder and got burst.The fluid was supposed to go into the bladder during an operative procedure, but someone put it into the inflation lumen of the foley.As per the follow-up information received on 10 aug 2020,10 cc of saline was used to inflate the balloon.No intervention or harm to patient.No pieces of balloon were missing.
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Manufacturer Narrative
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The reported event was confirmed as use-related.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities." 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 foley catheter with a 5 ml balloon was overinflated in a patient's bladder and got burst.The fluid was supposed to go into the bladder during an operative procedure, but someone put it into the inflation lumen of the foley.As per the follow-up information received on 10aug2020,10 cc of saline was used to inflate the balloon.No intervention or harm to patient.No pieces of balloon were missing.
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Search Alerts/Recalls
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