MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for DILATION PRODUCTS UNK manufactured by C.r. Bard, Inc. (covington) -1018233.
[120418033]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[120418034]
It was reported that the device was inflated with 5 ml water, and during an attempt to take the water out of the balloon, it would not come out. A clinician attempted to cut the catheter to drain the water, but that did not work. Consequently, a guidewire was placed in the inflation part of the catheter to cut the balloon, but this did not work either. Eventually the catheter was forced out of the patient. There was no reported patient injury. Per additional information from ibc via email (b)(6) 2018; there was no bleeding from the patient after the catheter was removed and no medication was given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-04190 |
| MDR Report Key | 7877488 |
| Date Received | 2018-09-14 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-11-02 |
| Device Manufacturer Date | 2018-05-02 |
| Date Added to Maude | 2018-09-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DILATION PRODUCTS |
| Generic Name | CATHETER |
| Product Code | FBW |
| Date Received | 2018-09-14 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-14 |