The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inlet port of the cap / catheter (fr.) thickness out of specification".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: "open package and remove plastic wallet.Open plastic wallet and don gloves.Pull catheter out of tube to desired length.Lay tube in sterile field.Open lubricant and lubricate catheter.Open swab packet.Cleanse vaginal area.Proceed with catheterization.Pull catheter out of top; tighten cover and depress blue spout.Fill out label, place on centrifuge tube.Send to lab in normal manner.Important: use plastic wallet as sterile field.Pull catheter out of centrifuge tube to the proper length immediately after donning gloves.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly." 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.H3 other text: the device was not returned.
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