MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for BARD? X-FORCE? BALLOON DILATION CATHETER 997604 manufactured by C.r. Bard, Inc. (covington) -1018233.
[142058587]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bd 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 bd.
Patient Sequence No: 1, Text Type: N, H10
[142058588]
It was reported that after breaking the package, the putter was found to be damaged. It was later reported per additional information received from the ibc,that the package was not broken. The putter was damaged when the package was opened. The type of damage is currently unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-01954 |
| MDR Report Key | 8515794 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-07-01 |
| Device Manufacturer Date | 2016-08-13 |
| Date Added to Maude | 2019-04-15 |
| 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 | 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 | BARD? X-FORCE? BALLOON DILATION CATHETER |
| Generic Name | BARD? X-FORCE? BALLOON DILATION CATHETER |
| Product Code | EZN |
| Date Received | 2019-04-15 |
| Returned To Mfg | 2019-05-15 |
| Model Number | 997604 |
| Catalog Number | 997604 |
| Lot Number | BMATFM34 |
| Device Expiration Date | 2019-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-04-15 |