MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2020-01-02 for BAKRI TAMPONADE BALLOON CATHETER G30673 J-SOS-100500 manufactured by Cook Inc.
[178149638]
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
[178149639]
It was reported that while treating a post partum hemorrhage, in which 800 ml of blood loss had already occurred, after a c-section a bakri tamponade balloon catheter was placed via the vagina with sponge forceps, but was found to leak after being inflated with 230 ml of saline. The operator implemented a "contraction treatment" along with the bakri. The operator then removed the device and found that the balloon had ruptured vertically, with the "split" measuring between 4 and 5 cm. Another bakri tamponade balloon catheter was placed to achieve hemostasis. 80 ml of blood was lost after the second bakri balloon was placed. It was reported that no adverse effects to the patient occurred due to this malfunction. Additional details have been requested regarding the patient and event. At this time no additional information has been provided. A follow up report will be submitted when additional details are received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00031 |
| MDR Report Key | 9538687 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2020-01-02 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-16 |
| Device Manufacturer Date | 2019-01-15 |
| Date Added to Maude | 2020-01-02 |
| 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 | UNK 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 | BAKRI TAMPONADE BALLOON CATHETER |
| Generic Name | OQY INTRAUTERINE BALLOON |
| Product Code | OQY |
| Date Received | 2020-01-02 |
| Returned To Mfg | 2020-01-13 |
| Model Number | G30673 |
| Catalog Number | J-SOS-100500 |
| Lot Number | 9448806 |
| 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 | 2020-01-02 |