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Model Number 33426 |
Device Problem
Inadequate Instructions for Healthcare Professional (1319)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2023 |
Event Type
malfunction
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Event Description
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It was reported that the patient ordered to have a 26fr urethral catheter exchanged.The catheter was exchanged using sterile technique.Urine return was observed.Upon inflating balloon sterile water sprayed out of the port above where the syringe was attached, and the registering nurse observed that that piece was dry rotted, so the catheter was promptly removed from the patient.After removal, the packaging was inspected for an expiration date by multiple registered nurses.There was no expiration date on the catheter or packaging.External catheter placed on the patient until another catheter could be obtained.Although no patient harm occurred, the patient would have to have a second insertion.
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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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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "incorrect/ missing translation (or) vendor/printer error".The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient ordered to have a 26fr urethral catheter exchanged.The catheter was exchanged using sterile technique.Urine return was observed.Upon inflating balloon sterile water sprayed out of the port above where the syringe was attached, and the registering nurse observed that that piece was dry rotted, so the catheter was promptly removed from the patient.After removal, the packaging was inspected for an expiration date by multiple registered nurses.There was no expiration date on the catheter or packaging.External catheter placed on the patient until another catheter could be obtained.Although no patient harm occurred, the patient would have to have a second insertion.
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Search Alerts/Recalls
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