C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
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Catalog Number 1758SI16 |
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 03/21/2024 |
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 there were issues recently with the surestep foley tray system.Customer had two occurrences of the balloon not deflating.
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Manufacturer Narrative
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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 "incorrect balloon design (balloon wall thickness excessive)".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: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.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" correction: a,b,f,h 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 there were issues recently with the surestep foley tray system.Customer had two occurrences of the balloon not deflating.Per follow-up information received on (b)(6) 2024, customer stated that was the only lot number affected.They never received the trays from their clinical education team and did not have them to send back.The trays were used in an education setting and were not used on the floors, so no patients were affected.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.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 "incorrect balloon design (balloon wall thickness excessive)".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: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.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.H3 other text : the device was not returned.
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Event Description
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It was reported that there were issues recently with the surestep foley tray system.Customer had two occurrences of the balloon not deflating.
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Search Alerts/Recalls
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