MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-29 for BARD 0035630 * manufactured by Cr Bard, Inc.
[259654]
Catheter inserted into pelvis to drain bladder. When it came time to remove catheter rn and md unable to do so. Seen by urologist who took pt to surgery to remove catheter. Single knot found upon surgical removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 413469 |
| MDR Report Key | 413469 |
| Date Received | 2002-08-29 |
| Date of Report | 2002-08-28 |
| Date of Event | 2002-04-25 |
| Date Facility Aware | 2002-04-25 |
| Report Date | 2002-08-28 |
| Date Added to Maude | 2002-08-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD |
| Generic Name | INFANT CATH KIT |
| Product Code | FFH |
| Date Received | 2002-08-29 |
| Model Number | 0035630 |
| Catalog Number | * |
| Lot Number | 76CM0801 |
| ID Number | 5 FR. CATHETER |
| Device Expiration Date | 2004-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 402518 |
| Manufacturer | CR BARD, INC |
| Manufacturer Address | * COVINGTON GA 30014 US |
| Baseline Brand Name | BARD INFANT CATH KIT |
| Baseline Generic Name | URINE SPECIMEN KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 0035630 |
| Baseline ID | NA |
| Baseline Device Family | INFANT, FEMALE AND PEDIATRIC CATH KITS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K905016 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-08-29 |