MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-18 for SL FOLEY SWIVEL 25BX FOL0101 manufactured by C.r. Bard, Inc. (covington) -1018233.
[186176055]
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
[186176056]
It was reported that the statlock would not stay closed around the foley catheter being used supra-pubically. The statlock would click closed when first applying, however once urine flowed through the catheter and the rubber tubing expanded due to the temperature change it did not remain closed. The patient was using the statlock with a size 18 fr and larger catheters. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01904 |
| MDR Report Key | 9851190 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-03-18 |
| 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 | SL FOLEY SWIVEL 25BX |
| Generic Name | STATLOCK |
| Product Code | EYJ |
| Date Received | 2020-03-18 |
| Catalog Number | FOL0101 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-18 |