|
Catalog Number 165818 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/12/2024 |
Event Type
malfunction
|
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.
|
|
Event Description
|
It was reported that they found black particle inside the foley catheters.Impacted product as follows (material #0170si12 and batch# nggq1259), (material #165818 and batch# nghv4431) and (material #165816 and batch# nghs0849).They were found prior to patient use and there was no patient impact.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿not following the production areas cleaning procedure".However, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure.That all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." 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 they found black particle inside the foley catheters.Impacted product as follows (material #0170si12 and batch# nggq1259), (material #165818 and batch# nghv4431), (material #165816 and batch# nghs0849).They were found prior to patient use and there was no patient impact.Per customer follow up received on 29mar2024, it was reported that the affected foleys were returned.The lots listed in the mentioned complaint were the only ones affect.As stated they were found before patient contact or use.
|
|
Search Alerts/Recalls
|
|
|