It was reported that davol female catheter kit was falling out of collection tube into patient, frequently thus causing them to have to fish out the tubing from the patient.Per additional information received via email on 29-aug-2022, there was no patient impact or injury.
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The reported event was confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.Although a specific cause cannot be determined, based on the risk document a potential root cause for this event could be ¿inlet port of the cap /catheter (fr.) thickness out of specification".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: "instructions for use: 1.Open package and remove plastic wallet.2.Open plastic wallet and don gloves.3.Pull catheter out of tube to desired length.Lay tube in sterile field.4.Open lubricant and lubricate catheter.5.Open swab packet.Cleanse vaginal area.6.Proceed with catheterization.7.Pull catheter out of top; tighten cover and depress blue spout.8.Fill out label, place on centrifuge tube.Send to lab in normal manner.Important: 1.Use plastic wallet as sterile field.2.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 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 actual/suspected device was inspected.
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