Catalog Number UNKNOWN |
Device Problem
Break (1069)
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Patient Problems
Bacterial Infection (1735); Erythema (1840); Thrombosis/Thrombus (4440)
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Event Date 01/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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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.Investigation summary: as no physical sample, 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.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Capa is not required at this time.
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Event Description
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It was reported that the cannula of an unspecified bd venflon catheter broke was damaged and broke inside the patient.The following information was provided by the initial reporter: tip of plastic canula once broken inside vein.Description / detail: ¿we have done imaging to localize it.¿ patient complication: ¿thrombosis.¿ description / detail: ¿double puncture.¿ patient complication: ¿infection.¿ description / detail: ¿erythema.¿.
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Manufacturer Narrative
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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.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, 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.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Capa is not required at this time.
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Event Description
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It was reported that the cannula of an unspecified bd venflon catheter broke was damaged and broke inside the patient.The following information was provided by the initial reporter: tip of plastic canula once broken inside vein.Description / detail: ¿we have done imaging to localize it.¿ patient complication: ¿thrombosis.¿ description / detail: ¿double puncture.¿ patient complication: ¿infection.¿ description / detail: ¿erythema.¿.
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Search Alerts/Recalls
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