Catalog Number 382533 |
Device Problem
Defective Component (2292)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Date 08/10/2023 |
Event Type
malfunction
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Event Description
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It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter with blood control the catheter tip was deformed.This occurred 10 times.There was no report of patient impact.The following information was provided by the initial reporter: i have had a complaint on the 20 ga insytes causes more pain and discomfort when starting iv for the last 2-3 weeks.3 out of 5 nurses have noticed the problem.When you start 6-8 ivs daily you can notice when something has changed.One nurse discovered the plastic at the end of the insyte are bulkier than the older ones.Response received 21 aug 2023 the plastic was at the tip of the catheter.It was more thicker at the tip than any other location on the catheter.We had several so i would say approximately 10-20 that was not reported until after several nurses complained, then that¿s when we investigated the situation.Missed iv¿s and patients complaining more about pain at insertion site.
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Manufacturer Narrative
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B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 29-aug-2023.Bd received an unsealed 20 gauge insyte autoguard blood control unit from lot 3129117 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the catheter tip was slightly deformed.Next, the engineer tested the returned unit for leakage but no leakage was observed.Therefore, based off the visual inspection and testing the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred during the catheter tipping process.
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Event Description
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It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter with blood control the catheter tip was deformed.This occurred 10 times.There was no report of patient impact.The following information was provided by the initial reporter: i have had a complaint on the 20 ga insytes causes more pain and discomfort when starting iv for the last 2-3 weeks.3 out of 5 nurses have noticed the problem.When you start 6-8 ivs daily you can notice when something has changed.One nurse discovered the plastic at the end of the insyte are bulkier than the older ones.Response received 21 aug 2023.The plastic was at the tip of the catheter.It was more thicker at the tip than any other location on the catheter.We had several so i would say approximately 10-20 that was not reported until after several nurses complained, then that¿s when we investigated the situation.Missed iv¿s and patients complaining more about pain at insertion site.
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Search Alerts/Recalls
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