Catalog Number 0035630 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/27/2017 |
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.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.The device was not returned.
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Event Description
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It was reported that the packet of betadine swab leaked within the kit.
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Event Description
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It was reported that the packet of betadine swab leaked within the kit.
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Manufacturer Narrative
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The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "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." (b)(4).
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Event Description
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It was reported that the packet of betadine swab leaked within the kit.
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Manufacturer Narrative
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The reported issue (it was reported that the betadine swab pack had leaked within the kit) was confirmed, as supplier related.Visual inspection found that the supplier seal was opened.The seal delaminated one side of the package.The seal was opened and leaked iodine in product components.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "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." 1267, 2645: "nl".
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Search Alerts/Recalls
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