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Catalog Number 175816 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that the registered nurse placed foley catheter, urine return noted, balloon inflated with 10cc syringe.Nurse placed catheter bag at end of bed.They went to reposition patient and noticed foley catheter tubing was severed from the foley balloon and laying in patient's bed.The tubing was found to be sliced in half, which left the tip of the foley along with the balloon inside of the patient.(nggz1611, nghg1002, nghq2185).
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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 "high modulus silicone / inadequate material selection".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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