MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-01-27 for BARDEX? MALECOT MODEL DRAIN 086014 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183789807]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183789808]
It was reported that a pinhole was found on the connection between the funnel and shaft. Per additional information received via email on 4 january 2020 from the investigator, the malecot was not made nor intended to have a balloon. However, a pinhole was found on the device. Per sample evaluation, it was found that there was a protrusion coming from the malecot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00555 |
| MDR Report Key | 9634648 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-01-27 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-01-11 |
| Date Added to Maude | 2020-01-27 |
| 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 | 3 |
| Brand Name | BARDEX? MALECOT MODEL DRAIN |
| Generic Name | URETHERAL CATHETER |
| Product Code | FEW |
| Date Received | 2020-01-27 |
| Returned To Mfg | 2019-12-10 |
| Model Number | 086014 |
| Catalog Number | 086014 |
| Lot Number | MCCY3272 |
| 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 | 2020-01-27 |