Catalog Number UNKNOWN |
Device Problem
Air/Gas in Device (4062)
|
Patient Problem
Air Embolism (1697)
|
Event Date 05/16/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.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.
|
|
Event Description
|
It was reported that the unspecified bd infusion set experienced air bubbles.The following information was provided by the initial reporter: large amount of air in the right ventricle and pulmonary artery.
|
|
Event Description
|
It was reported that the unspecified bd infusion set experienced air bubbles.The following information was provided by the initial reporter: large amount of air in the right ventricle and pulmonary artery.
|
|
Manufacturer Narrative
|
H6: investigation summary no product or photo was returned by the customer.The customer complaint that there was large amounts of air could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.
|
|
Search Alerts/Recalls
|