MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2019-12-12 for PROXIS? URETERAL ACCESS SHEATH 231035 manufactured by C.r. Bard, Inc. (covington) -1018233.
[176777764]
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
[176777765]
It was reported that the coating on the access sheath peeled off during the procedure. All fragments of the peeling was collected, and no pieces remained in the patient's body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-07913 |
| MDR Report Key | 9459916 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2019-12-12 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-11-06 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-04-22 |
| Date Added to Maude | 2019-12-12 |
| 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 | PROXIS? URETERAL ACCESS SHEATH |
| Generic Name | ACCESS SHEATH |
| Product Code | FED |
| Date Received | 2019-12-12 |
| Returned To Mfg | 2019-12-02 |
| Model Number | 231035 |
| Catalog Number | 231035 |
| Lot Number | BMDRFM07 |
| 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 | 2019-12-12 |