Model Number 143112 |
Device Problems
Component Missing (2306); Component Misassembled (4004)
|
Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/09/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
|
Event Description
|
It was reported that the suprapubic catheter kit that had the luer-lock hub for filling the balloon was missing in the kit.Follow up via phone on 06nov2020, the device was not used on a patient.
|
|
Event Description
|
It was reported that the suprapubic catheter kit had the luer-lock hub for filling the balloon was missing in the kit.Per follow-up via phone on 06nov2020, the device was not used on a patient.
|
|
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 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.
|
|
Manufacturer Narrative
|
The reported event was confirmed as manufacturing-related.One sample was confirmed to exhibit the reported failure.An amber two way foley catheter was returned without its original packaging.The inflation valve of the catheter was found to be missing.Product does not meet specification which states "each catheter will have the valve and cap checked for proper valve and cap placement, print presence, and any valve or cap defect such as cracked valves, cracked caps, short valve/cap assemblies etc." a potential root cause for this failure could be "machine malfunction".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed as the reported event was confirmed as manufacturing related.Correction: h.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.The actual/suspected device was inspected.
|
|
Event Description
|
It was reported that the suprapubic catheter kit had the luer-lock hub for filling the balloon was missing in the kit.Per follow-up via phone on (b)(6) 2020, the device was not used on a patient.
|
|
Search Alerts/Recalls
|