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Catalog Number 175814 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2023 |
Event Type
malfunction
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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.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.
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Event Description
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It was reported that the additional lots of foley catheter balloons were not deflating.(lot# nghw2270) and (lot# nghw0236).
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Event Description
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It was reported that the additional lots of foley catheter balloons were not deflating.(lot# nghw2270) and (lot# nghw0236).
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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 due to "incorrect balloon design (balloon wall thickness excessive)".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "foley catheter removal: to deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation if the balloon will not deflate and 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." 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.
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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 due to "incorrect balloon design (balloon wall thickness excessive)".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "foley catheter removal: 1.To deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.2.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.3.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.4.If the balloon will not deflate and 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.5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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.
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Event Description
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It was reported that the additional lots of foley catheter balloons were not deflating.(lot# nghw2270) and (lot# nghw0236).Per follow up via email on 11jan2024, it was stated that they had 2 of these for 2 different products.One was from a month ago, they had the specific device red bagged, it took 4 hours to remove the foley catheter from the patient in the maternal care unit (lot#nghv4224) and one was from last week.They did not have the device.The balloon would not deflate in the operating room and had to be cut in order to remove (lot#nghx2351).
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Search Alerts/Recalls
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