Catalog Number UNKNOWN |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2021 |
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.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 unspecified bd¿ 22 g saf-t-intima catheter was defective.This occurred on 4 occasions.The following information was provided by the initial reporter: it was reported that the iv's are failing.Verbatim: i received the letter confirming that there was 4 out of 19 iv's i sent that failed the testing.I agree that this is the percentage overall in my clinic of these iv's failing.It has also been reported to me from nurses that this is an issue with the intimas at other facilities.About 25% failure rate with the 24 gauge and some of the 22 gauge intimas are now failing.This a serious impact on patient care, especially in the oncology setting.
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Manufacturer Narrative
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Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text.
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Event Description
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It was reported that unspecified bd¿ 22 g saf-t-intima catheter was defective.This occurred on 4 occasions.The following information was provided by the initial reporter: it was reported that the iv's are failing.Verbatim: i received the letter confirming that there was 4 out of 19 iv's i sent that failed the testing.I agree that this is the percentage overall in my clinic of these iv's failing.It has also been reported to me from nurses that this is an issue with the intimas at other facilities.About 25% failure rate with the 24 gauge and some of the 22 gauge intimas are now failing.This a serious impact on patient care, especially in the oncology setting.
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Search Alerts/Recalls
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