Catalog Number UNKNOWN |
Device Problem
Malposition of Device (2616)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/18/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
|
|
Event Description
|
It was reported that while in hospital patient used the purewick system.The patient advised the nurse shoved the purewick inside, and advised hospital management issue.
|
|
Manufacturer Narrative
|
The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for discharge urine.It was unknown whether the product had caused the reported failure.The lot number was unknown therefore the device history record could not be reviewed.The labeling review was unable to review due to the unknown product code.Although the product family was unknown the (purewick) ifu's are found to be adequate based on past reviews.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.
|
|
Event Description
|
It was reported that while in hospital patient used the purewick system.The patient advised the nurse shoved the purewick inside, and advised hospital management issue.
|
|
Search Alerts/Recalls
|