MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for URETERAL CATHS 119316M UNK manufactured by C.r. Bard, Inc. (covington) -1018233.
[146982692]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[146982693]
It was reported that the during the removal of the temp sensing foley; the nurse fully deflated the balloon and tried to pull the catheter from the patient; however; there was resistance at end. The catheter was able to be removed with extra lubricant. The patient was not in any distress and did not indicate any discomfort after removal. Upon inspection of catheter, it was noted that there was a hard ring encircled the tubing near catheter tip. The nurse inflated the catheter balloon, which inflated appropriately, and the ring was gone after deflation. The unknown catheter is part of tray#: a339516am.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-02773 |
| MDR Report Key | 8649693 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-06-06 |
| Date Mfgr Received | 2019-06-05 |
| Date Added to Maude | 2019-05-29 |
| 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 | 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 | URETERAL CATHS |
| Generic Name | UNKNOWN SILICONE TSENSING FOLEY |
| Product Code | EYB |
| Date Received | 2019-05-29 |
| Model Number | 119316M |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-29 |