MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-29 for BAKRI TAMPONADE BALLOON CATHETER J-SOS-100500 manufactured by Cook Inc.
[98976803]
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[98976804]
The following information was reported for a hemostasis procedure: the user inflated the balloon with 50ml of saline prior to patient contact and didn't find any damage in the balloon. The balloon was deflated and inserted into the patient; the balloon was inflated with approximately 150ml of saline. The bleeding stopped, but started again after approximately 2 hours so the balloon catheter was removed. The same balloon catheter was then reinserted and the balloon was inflated with approximately 120ml of saline. The cervix was pulled with forceps to perform local anesthesia and water came out with a splashing sound. The balloon catheter was removed and it was noted that the balloon had a tear that was approximately 5cm. Another device (same kind) was placed in the patient. The user noted that the balloon did not come in contact with any hard object and there was no damage on the balloon when it was inserted. There were no reported adverse effects to the patient as a result of the reported product problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00284 |
| MDR Report Key | 7224118 |
| Date Received | 2018-01-29 |
| Date of Report | 2018-01-29 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2015-08-30 |
| Date Added to Maude | 2018-01-29 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BAKRI TAMPONADE BALLOON CATHETER |
| Generic Name | KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC |
| Product Code | KNA |
| Date Received | 2018-01-29 |
| Catalog Number | J-SOS-100500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-01-29 |