Model Number 000286 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
For the reported event, lot number was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.
|
|
Event Description
|
This report summarizes one malfunction.A review of the reported information indicated that model 000286 feeding tube allegedly experienced leak / splash.It was further reported that another device was used to complete the procedure.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is (b)(6) years old, female; however, weight was not provided.
|
|
Manufacturer Narrative
|
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation of the device did not identify a leak.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h6(methods, results, conclusion) h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Event Description
|
This report summarizes one malfunction.A review of the reported information indicated that model 000286 feeding tube allegedly experienced leak / splash.It was further reported that another device was used to complete the procedure.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is 3 year old, female; however, weight was not provided.
|
|
Search Alerts/Recalls
|