Catalog Number UNKNOWN |
Device Problem
Leak/Splash (1354)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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" optima injector separated from the tubing and leaked blood.The following information was provided by the initial reporter: it was reported by the facility representative that the tubing disconnected from the injector causing blood to leak out of the lumen.
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Event Description
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It was reported that unspecified bd¿ optima injector separated from the tubing and leaked blood.The following information was provided by the initial reporter: it was reported by the facility representative that the the tubing disconnected from the injector causing blood to leak out of the lumen.
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Manufacturer Narrative
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H6: investigation summary: one photo was provided to our quality team for investigation.While the injector cannot be observed in the photo, it can be concluded the reported disconnection occurred between the luer connection of the optima device and iv tubing and a leakage can be observed within the photo.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimension such a luer threading are within specification.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.It is important to ensure all luer connections are securely tightened.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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