Catalog Number 381411 |
Device Problems
Product Quality Problem (1506); Suction Problem (2170)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that bd insyte-n¿ autoguard¿ shielded iv catheter did not get a flash back like they used to.The following information was provided by the initial reporter: material no.381411, batch no.Unknown.It was reported there is an issue with the 24 ga insyte catheter.I am contacting you about a problem that the special care nursery is having with the 24 ga insyte catheter #381411.The manager of the area said that she noticed a change in packaging and since that occurred they are having problems with the product.The package changed with the 24 g insytes, since then the staff have noticed that when they use them they don¿t get a flash back like they used to.Unfortunately this has happened with multiple patients and multiple staff before they realized it could be a product issue.Three specific patients had more than 7 attempts and on two patients central lines were placed because they could not obtain iv access with these newborns in our special care.
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Event Description
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It was reported that bd insyte-n¿ autoguard¿ shielded iv catheter did not get a flash back like they used to.The following information was provided by the initial reporter: material no.381411 batch no.Unknown it was reported there is an issue with the 24 ga insyte catheter.I am contacting you about a problem that the special care nursery is having with the 24 ga insyte catheter #381411.The manager of the area said that she noticed a change in packaging and since that occurred they are having problems with the product.The package changed with the 24 g insytes, since then the staff have noticed that when they use them they don¿t get a flash back like they used to.Unfortunately this has happened with multiple patients and multiple staff before they realized it could be a product issue.Three specific patients had more than 7 attempts and on two patients central lines were placed because they could not obtain iv access with these newborns in our special care.
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Manufacturer Narrative
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Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Dhr could not be performed.Root cause could not be determined.
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Search Alerts/Recalls
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