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
Activation Problem (4042)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/21/2023 |
Event Type
malfunction
|
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 manufacturer has received the sample and will evaluate.Results are expected soon.
|
|
Event Description
|
It was reported that when removing the device from the port body, the safety mechanism didn¿t work.However, the safety mechanism finally worked.There was no reported patient injury.
|
|
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 complaint of the safety mechanism of a safestep not working is unconfirmed because the problem could not be reproduced.The returned product was one 22 ga x 0.75 in safestep infusion set.An initial visual observation showed the safety mechanism was activated upon return of the device, and use residues were evident throughout the returned infusion set.A functional test of disengaging the safety and reengaging the safety mechanism of the needle revealed nothing remarkable.The safety mechanism did not prove difficult to engage during a functional test with the complainant infusion set.The complaint of an infusion set safety mechanism not functioning properly is unconfirmed because the problem could not be reproduced.The safety was activated upon receipt and further appeared to function as intended during evaluation.H3 other text : evaluation findings are in section h.11.
|
|
Event Description
|
It was reported that when removing the device from the port body, the safety mechanism didn¿t work.However, the safety mechanism finally worked.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|