C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/12/2024 |
Event Type
malfunction
|
Event Description
|
It was reported by the customer that for three patients, the needle began to separate from the flat padded piece that sits against the skin (the needle began to retract, pulling away from the reservoir where it had been inserted).The patients began to bleed around the insertion site, their ports needed to be de-accessed and accessed again with a new needle.It was stated "there was no specific harm but these are pediatric patients and it is traumatic to have their ports accessed." it was reported this occurred with three devices.This report addresses the first device.
|
|
Manufacturer Narrative
|
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.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
|
|
Search Alerts/Recalls
|
|
|