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Catalog Number 0035640 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that the nurse was using 8 french pediatric catheter kit on a 10 month old baby in order to rule out urinary tract infection.Sterile container fell off catheter on its own during procedure.Also, lube was needed scissors to be opened because the perforations on lube would not let it open.This caused urine to not to be collected and intervention was needed.This caused a urine bag to be placed, but if the urine collected from bag has an abnormal dipstick result, another catheter would be needed to be performed.Another catheter kit with the same lot number was opened and had the same malfunctions as the kit used on the patient.
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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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Manufacturer Narrative
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The reported event was confirmed cause unknown.1sample were confirmed to exhibit the reported failure.The device had not met specifications.A potential root cause for this failure mode 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: ¿single use.Do not resterilize.Do not use if package is damaged.Not made with natural rubber latex.Instructions for use: 1.Open package and remove plastic wallet.2.Open plastic wallet.3.Place infant in supine position, thighs abducted.4.Cleanse the area around the meatus with povidone-iodine swabs.5.Put on sterile gloves.6.Place the tip of the catheter in sterile lubricant and catheterize patient.7.After urine is collected, pull catheter out of cap.8.Tighten cap and depress spout.9.Label centrifuge tube.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.8 fr.Catheter in centrifuge tube.Povidone-iodine swabs, vinyl gloves.3 gm lubricant.Towel.Label".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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Event Description
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It was reported that the nurse was using 8 french pediatric catheter kit on a 10 month old baby in order to rule out urinary tract infection.Sterile container fell off catheter on its own during procedure.Also, lube was needed scissors to be opened because the perforations on lube would not let it open.This caused urine to not to be collected and intervention was needed.This caused a urine bag to be placed, but if the urine collected from bag has an abnormal dipstick result, another catheter would be needed to be performed.Another catheter kit with the same lot number was opened and had the same malfunctions as the kit used on the patient.
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Search Alerts/Recalls
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