Catalog Number 367284 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hematoma (1884)
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Event Date 05/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is nipro.This site is an oem manufacturing site.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.Medical device lot #: reported as om2882 - nipro does not have om2882.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was tube push off non-patient end needle.The following information was provided by the initial reporter.The customer stated: the "tube is popping off, sometimes leaving a hematoma on the kid's arm.Some kids have to be redrawn.".
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Event Description
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It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was tube push off non-patient end needle.The following information was provided by the initial reporter.The customer stated: the "tube is popping off, sometimes leaving a hematoma on the kid's arm.Some kids have to be redrawn.".
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Manufacturer Narrative
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Correction: d4: medical device lot #: 21a04t2.H6: investigation summary bd had not received samples or photos for investigation.Therefore, 15 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to push off as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode push off.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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