Device Problem
Incorrect Measurement (1383)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/21/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the tip of the foley catheter was larger than it used to be aside from the size of the tip, and it was also harder and stiffer.
|
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be " operator error ".The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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.
|
|
Event Description
|
It was reported that the tip of the foley catheter was larger than it used to be aside from the size of the tip, and it was also harder and stiffer.
|
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
|
|
Event Description
|
It was reported that the tip of the foley catheter was larger than it used to be aside from the size of the tip, and it was also harder and stiffer.
|
|
Search Alerts/Recalls
|