BAKRI BALLOON

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for BAKRI BALLOON manufactured by Cook, Inc..

Event Text Entries

[176387410] On (b)(6) 2019 my wife was admitted to (b)(6) in active labor. During her admission on (b)(6) 2019, my wife had a postpartum hemorrhage post vaginal delivery. The staff attempted to use a bakri balloon during their code obert to control bleeding. On the first attempt of inserting and inflating the bakri balloon, charge nurse (b)(6) stated that the balloon had hole and was not able to be used. A second bakri was obtained, but the device was no readily available in the room, thus causing a delay in my wife's care. Once the second balloon was finally obtained, charge nurse (b)(6) attempted to inflate the balloon while dr (b)(6) inserted it, during the attempt the syringe became disconnected causing the solution inside the syringe to splash dr (b)(6) on his face shield. Charge nurse (b)(6) then reattached the syringe and used the remaining solution and attempted to inflate the bakri balloon. Unfortunately, at this point staff stated that the balloon was unable to properly inserted and inflated due to my wife's contracted uterus. It was estimated at this time that my wife had lost 1300ml of blood. A decision was made to take her to the operating room in labor and delivery. While in the operating room it was decided that an emergency total abdominal hysterectomy was needed in order to stop the acute hemorrhage after multiple failed bakri attempts. Dr (b)(6) spoke with me personally after the surgery while i was in the nursery with my newborn and reviewed with me what transpired. Dr (b)(6) stated that it was reported that first bakri balloon per staff was defective and second bakri balloon was unable to be inserted because uterus was too contracted. Dr (b)(6) also reviewed with me interventions that were preformed and further plan of care of my wife with blood product transfusions and plan of care. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092410
MDR Report Key9621802
Date Received2020-01-22
Date of Report2020-01-21
Date of Event2019-08-29
Date Added to Maude2020-01-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameBAKRI BALLOON
Generic NameINTRAUTERINE TAMPONADE BALLOON
Product CodeOQY
Date Received2020-01-22
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOOK, INC.

Device Sequence Number: 2

Brand NameBAKRI BALLOON
Generic NameINTRAUTERINE TAMPONADE BALLOON
Product CodeOQY
Date Received2020-01-22
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerCOOK, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Deathisabilit 2020-01-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.