MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-06 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS G24237 J-SOSR-100500 manufactured by Cook Inc.
[178142034]
Pma/510k #: k170622. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[178142035]
It was reported that during a bakri balloon insertion for management of a postpartum hemorrhage due to cervical laceration and uterine atony, the syringe of the cook bakri postpartum balloon with rapid instillation components broke off in the hub preventing inflation. Around four hours after delivery, the patient had lost 2500 ml of blood and the first cook bakri balloon was placed transvaginally. After it was placed the balloon was being filled with saline when the syringe broke off within the stopcock. Another bakri balloon was used to achieve hemostasis. The patient received four units of prbc after losing 1500 ml of blood. No adverse effects related to the alleged malfunction were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00300 |
| MDR Report Key | 9677782 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-06 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-11-20 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS |
| Generic Name | OQY INTRAUTERINE BALLOON |
| Product Code | OQY |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-02-13 |
| Model Number | G24237 |
| Catalog Number | J-SOSR-100500 |
| Lot Number | 10162713 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |