Catalog Number 383954 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd pegasus¿ safety closed iv catheter system leaked medication from the tubing.The following information was provided by the initial reporter, translated from chinese: "the head nurse of the operating room reported that during the use of the product for the patient, the extension tube was found to come out of the y-shaped interface, resulting in drug liquid leakage, and the patient was dissatisfied.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 18-aug-2022.Investigation summary: in response to the event reported, a device history review was conducted for lot number 1293369.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally a sample was returned to our facility which displayed an extension tube that had been separated from the y-shaped housing.The issue has been confirmed.Based on the visual analysis of the device, our engineers have determined that the root cause for this event is related to the swaging process.Swaging is implemented to ensure that the cavity which houses the tubing and metal cuff is of an optimized depth.A shallow cavity can result in the tubing becoming displaced from the housing.To prevent future occurrences of this event our engineers have issued a retraining to the relevant personnel.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the bd pegasus¿ safety closed iv catheter system leaked medication from the tubing.The following information was provided by the initial reporter, translated from chinese: "the head nurse of the operating room reported that during the use of the product for the patient, the extension tube was found to come out of the y-shaped interface, resulting in drug liquid leakage, and the patient was dissatisfied".
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Search Alerts/Recalls
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