Catalog Number 165816 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/29/2023 |
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.
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Event Description
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It was reported that customer had some foley catheter balloon issues regarding inflation (lot#nghs0594 and lot#nghq1143) or deflation recently (lot#nghs0594 and lot#nghq1143).
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Event Description
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It was reported that customer had some foley catheter balloon issues regarding inflation (lot#nghs0594 and lot#nghq1143) or deflation recently (lot#nghs0594 and lot#nghq1143).
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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 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: "bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip syringes (fig.1b).1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing if necessary and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab." 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.
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Search Alerts/Recalls
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