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Catalog Number 175812 |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2023 |
Event Type
malfunction
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Event Description
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It was reported that the district nurse visited for catheter change due to urinary tract infection, observations and to obtain a sample.Antibiotics commenced that morning.The patient had history of multiple sclerosis (ms), an enlarged prostate and a large bladder stone, recurrent urinary tract infections.The previous catheter was removed with no issues, some sediment was noted in urine in leg bag.A new catheter inserted, had some resistance and was unable to advance the catheter any further.The balloon inflated and then waited for draining.While waiting encouraged fluids and got patient to stand up.After around 30 minutes no urine had drained.The patient was not in discomfort.Stated that the patient did not had usual pain response, so it was not a good indicator of anything.They tried to deflate the balloon and reposition catheter.However when attaching syringe, it did not spontaneously fill as usual, so they pulled back and only 2ml was in syringe.They tried a different 10ml syringe however faced the same issue.They re-inserted the 2mls and phoned back to office for advice.The clinic nurse checked catheter policy and advice was to leave a 10ml syringe on for a few minutes to see if it would spontaneously fill, this was unsuccessful.Advised to change leg bag, also unsuccessful.
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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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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 "incorrect balloon design".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.1.Open outer white wrapping to prepare sterile field and place underpad beneath patient, plastic side down.2.If patient has a catheter in-situ to deflate catheter balloon: gently insert a luer 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, reseat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.Wait at least 30 seconds for deflation.If permitted by local protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance as directed by local protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.3.Put on gloves, cover patient with fenestrated drape with open exposing location where catheter will be inserted, and place the apron on yourself.4.Using the two (2) syringes, marked ¿for cleansing purposes only¿, dispense the water onto three (3) gauze squares.Prepare the patient by wiping down the catheter insertion site with the saturated gauze squares.Dry patient with the remaining two (2) gauze squares.Note: do not use this syringe to inflate the catheter balloon.5.Prepare the lubricating gel syringe by removing the cap from the syringe tip.6.For easing with the insertion of the catheter into the patient dispense the lubricating gel into the urethra (according to local protocol).7 remove top tray and open plastic pouch (sleeve) surrounding the catheter.8.Proceed with catheterisation according to local protocol.To inflate catheter, simply insert tip of sterile water-filled syringe gently into valve (do not over penetrate) and depress plunger.Instill entire amount of sterile water - 10 ml." 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 district nurse visited for catheter change due to urinary tract infection, observations and to obtain a sample.Antibiotics commenced that morning.The patient had history of multiple sclerosis (ms), an enlarged prostate and a large bladder stone, recurrent urinary tract infections.The previous catheter was removed with no issues, some sediment was noted in urine in leg bag.A new catheter inserted, had some resistance and was unable to advance the catheter any further.The balloon inflated and then waited for draining.While waiting encouraged fluids and got patient to stand up.After around 30 minutes no urine had drained.The patient was not in discomfort.Stated that the patient did not had usual pain response, so it was not a good indicator of anything.They tried to deflate the balloon and reposition catheter.However when attaching syringe, it did not spontaneously fill as usual, so they pulled back and only 2ml was in syringe.They tried a different 10ml syringe however faced the same issue.They re-inserted the 2mls and phoned back to office for advice.The clinic nurse checked catheter policy and advice was to leave a 10ml syringe on for a few minutes to see if it would spontaneously fill, this was unsuccessful.Advised to change leg bag, also unsuccessful.
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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 "incorrect balloon design".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: "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.1.Open outer white wrapping to prepare sterile field and place underpad beneath patient, plastic side down.2.If patient has a catheter in-situ to deflate catheter balloon: gently insert a luer 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, reseat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.Wait at least 30 seconds for deflation.If permitted by local protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance as directed by local protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.3.Put on gloves, cover patient with fenestrated drape with open exposing location where catheter will be inserted, and place the apron on yourself.4.Using the two (2) syringes, marked ¿for cleansing purposes only¿, dispense the water onto three (3) gauze squares.Prepare the patient by wiping down the catheter insertion site with the saturated gauze squares.Dry patient with the remaining two (2) gauze squares.Note: do not use this syringe to inflate the catheter balloon.5.Prepare the lubricating gel syringe by removing the cap from the syringe tip.6.For easing with the insertion of the catheter into the patient dispense the lubricating gel into the urethra (according to local protocol).7 remove top tray and open plastic pouch (sleeve) surrounding the catheter.8.Proceed with catheterisation according to local protocol.To inflate catheter, simply insert tip of sterile water-filled syringe gently into valve (do not over penetrate) and depress plunger.Instill entire amount of sterile water - 10 ml." 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 district nurse visited for catheter change due to urinary tract infection, observations and to obtain a sample.Antibiotics commenced that morning.The patient had history of multiple sclerosis (ms), an enlarged prostate and a large bladder stone, recurrent urinary tract infections.The previous catheter was removed with no issues, some sediment was noted in urine in leg bag.A new catheter inserted, had some resistance and was unable to advance the catheter any further.The balloon inflated and then waited for draining.While waiting encouraged fluids and got patient to stand up.After around 30 minutes no urine had drained.The patient was not in discomfort.Stated that the patient did not had usual pain response, so it was not a good indicator of anything.They tried to deflate the balloon and reposition catheter.However when attaching syringe, it did not spontaneously fill as usual, so they pulled back and only 2ml was in syringe.They tried a different 10ml syringe however faced the same issue.They re-inserted the 2mls and phoned back to office for advice.The clinic nurse checked catheter policy and advice was to leave a 10ml syringe on for a few minutes to see if it would spontaneously fill, this was unsuccessful.Advised to change leg bag, also unsuccessful.
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