MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-01-24 for SL FOLEY SWIVEL 25BX FOL0101 manufactured by C.r. Bard, Inc. (covington) -1018233.
[178198242]
The reported event was confirmed. Visual inspection noted one used foley statlock was received. An in-house foley catheter was placed in the clamp and the clamp was able to close down around the catheter properly. The catheter was pulled down with force to ensure that the clamp door remained closed, and it was found that the swivel base was disconnecting from the pad. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use were found adequate and state the following: "warnings and precautions: do not use the statlock? Device where loss of adherence could occur, such as with a confused patient, diaphoretic or non-adherent skin, or when the access device is not monitored daily. Observe universal blood and body fluid precautions and infection control procedures, during application and removal of the statlock? Device. Minimize catheter manipulation during application and removal of the statlock? Device. Daily maintenance: the statlock? Device should be assessed daily and changed when clinically indicated, at least every seven days. If pad becomes soiled, wash with soap/water, saline or hydrogen peroxide. Do not use alcohol or prepackaged bathing systems, which could lead to early lifting. If showering/bathing, cover with plastic wrap or waterproof dressing. Conduct skin assessment prior to application and repeat daily per facility protocol. Use clinical judgment on the removal of the statlock? Stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity. "
Patient Sequence No: 1, Text Type: N, H10
[178198243]
It was reported that the swivel base was disconnecting from the pad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00506 |
| MDR Report Key | 9629215 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2019-07-14 |
| Date Added to Maude | 2020-01-24 |
| 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 | FOLEY CATHETERS |
| Product Code | EYJ |
| Date Received | 2020-01-24 |
| Returned To Mfg | 2019-12-16 |
| Catalog Number | FOL0101 |
| Lot Number | JUDUF088 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2020-01-24 |