Model Number 406047 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Oem manufacture: the manufacturing location for this product is hdq us (b)(4).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.Device expiration date: unknown.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 that 2 tray epid cont we18g3.5 c20 lor5 s/l/l-e experienced needle hub holes.The following information was provided by the initial reporter: this week we had two connectors in your epidural kit that had a hole in the side.Ok both instances we were able to break open another type of kit and use theirs, but i wanted to let you know.
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Event Description
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It was reported that 2 tray epid cont we18g3.5 c20 lor5 s/l/l-e experienced needle hub holes.The following information was provided by the initial reporter: this week we had two connectors in your epidural kit that had a hole in the side.Ok both instances we were able to break open another type of kit and use theirs, but i wanted to let you know.
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Manufacturer Narrative
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H6: investigation summary one photo was provided to our quality team for investigation.Based on the provided photo, the reported failure was not confirmed.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.
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Search Alerts/Recalls
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