MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for BARD FOLEY CATHETER 1758SI14 manufactured by C. R. Bard, Inc..
[183099404]
Around change of shift i saw blood enter the tubing of the pt's foley catheter. Both the day shift and i were surprised and then the urine started becoming yellow again. Day shift stated that the pt must have accidentally tugged on the catheter, but catheter was anchored well. Then the foley came out of the penis with balloon deflated. Had to order new non-latex catheter 14f. Catheter inserted balloon inflated and slid out with balloon deflated. Balloon tested and a small hole leaked when attempted to inflate balloon. Two more attempts to insert foley resulted the same exact way. One balloon was inflated with only 5ml, both a 14f and a 16f were tried. Two reference numbers of the 4 catheters are (b)(4) and (b)(4). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093636 |
| MDR Report Key | 9810904 |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-29 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD FOLEY CATHETER |
| Generic Name | CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES |
| Product Code | MJC |
| Date Received | 2020-03-09 |
| Model Number | 1758SI14 |
| Catalog Number | 1758SI14 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Brand Name | BARD FOLEY CATHETER |
| Generic Name | CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES |
| Product Code | MJC |
| Date Received | 2020-03-09 |
| Model Number | 1758SI14 |
| Catalog Number | 1758SI14 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Brand Name | BARD FOLEY CATHETER |
| Generic Name | CATHETER RETENTION TYPE, BALLOON |
| Product Code | EZL |
| Date Received | 2020-03-09 |
| Model Number | A947316 |
| Catalog Number | A947316 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Brand Name | BARD FOLEY CATHETER |
| Generic Name | CATHETER RETENTION TYPE, BALLOON |
| Product Code | EZL |
| Date Received | 2020-03-09 |
| Model Number | A947316 |
| Catalog Number | A947316 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-09 |