Model Number 0605550 |
Device Problem
Material Frayed (1262)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
|
|
Event Description
|
This report summarizes one malfunction.A review of the reported information indicated that model 0605550.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no patient consequences.The patient is (b)(6) years of age, the gender is female, and the weight is (b)(6) kgs.
|
|
Manufacturer Narrative
|
H10.For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The investigation is confirmed for guidewire breakage/unraveling.A root cause has not been determined.The device is labeled for single use.H10: g4 h11: h6 (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 0605550.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no patient consequences.The patient is 5 years of age, the gender is female, and the weight is 16 kgs.
|
|
Search Alerts/Recalls
|