Hcp reported the patient continued to bleed was taken back to the operating room (or) where a dilation and curettage (d&c) was performed.[device ineffective] hcp stated he inserted another device but did not perform a sweep prior to doing so [wrong technique in device usage process] case narrative: this spontaneous report originating from united states was received from a healthcare professional via clinical account specialist (cas), referring to a non-pregnant female patient of unknown age.The patient¿s current condition included uterine atony, gravida 2 and para 1.The patient¿s historical condition included pregnancy, and caesarean section.The patient¿s concomitant medication included uterotonics (unknown medication).This report concerned 1 patient and 1 device.On (b)(6) 2023, the patient was inserted with (jada system) (device number 2) but did not perform a sweep prior to doing so (wrong technique in device usage process) and patient continued to bleed, was taken back to the operating room where dilation and curettage (d&c) was performed (device ineffective) after then patient stopped bleeding.It was reported the patient lost approximately 4000 ml and received blood transfusion (amount was unknown) during peripartum period.It was the provider's first time using the vacuum-induced hemorrhage control system (jada system).The patient sought medical attention.The reporter does not have any patient or device information.No product quality compliant (pqc) was reported.The availability of vacuum-induced hemorrhage control system (jada system) (device number 2) was unknown.For vacuum-induced hemorrhage control system (jada system) (device number 2) lot number and serial number were not provided.Upon internal review, the event of device ineffective was determined to be serious due to following reason: required intervention.This was one of the two reports received from the same reporter referring to same patient.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury fda code: (health effects - health impact per annex f): 4643 (patient required an infusion of whole blood or a blood component directly into the bloodstream.) fda code: (health effects - health impact per annex f): 4624 surgical interventions (one or more surgical procedures was required, or an existing procedure changed).
|