Catalog Number UNKNOWN |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that 2 unspecified bd nexiva experienced leakage that may have contributed to pain/swelling from a damaged/deformed product.The following information was provided by the initial reporter: "patient had 2 iv's, one was leaking/infiltrated.
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Manufacturer Narrative
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Device expiration date: unknown.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.
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Manufacturer Narrative
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H.6.Investigation summary: as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.
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Event Description
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It was reported that 2 unspecified bd nexiva experienced leakage that may have contributed to pain/swelling from a damaged/deformed product.The following information was provided by the initial reporter: "patient had 2 iv's, one was leaking/infiltrated.
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Search Alerts/Recalls
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