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.Device manufacture date: unknown.(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received. the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: part number and lot number is unknown; a lot history review could not be performed.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.
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It was reported that the unspecified bd¿ iv catheter infiltrated the patient's vein during use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "it was reported that catheters are hard to thread causing multiple sticks to the patient, blowing and infiltrating veins, wings are causing damages to the patients skin, and needles are flimsy.".
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