MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-06 for BARD UROLOGICAL CATHETER UNK * manufactured by Bard. C.r. Bard, Inc..
[500118]
Patient with history of empyema had 3 malecot catheters inserted for optimal drainage. The patient had a partial rib resection as well. Six weeks and 4 days later the patient returned to the clinic to have the drains removed. The tip of the last catheter to be removed remained inside the patient confirmed by the cat scan. The patient was taken to the or the next day and the retained foreign object was surgically removed. Please note: the surgeon states that he applied 'normal'; traction when pulling catheters out. Traction was equal for all three. Also, upon review of the tip - it was such a 'clean' break at the bendable portion of the malecot tip that it looked cut but was not. There are 4 'spokes' that create a flange appearance. Three of the 4 gave way right at the 'bent' portion. The 4th 'spoke' held. Pictures taken of catheter tip for future reference if needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036876 |
| MDR Report Key | 746369 |
| Date Received | 2005-10-06 |
| Date of Report | 2005-10-06 |
| Date of Event | 2005-09-07 |
| Date Added to Maude | 2006-08-14 |
| 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 | 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 UROLOGICAL CATHETER |
| Generic Name | MALECOT |
| Product Code | FEW |
| Date Received | 2005-10-06 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 734161 |
| Manufacturer | BARD. C.R. BARD, INC. |
| Manufacturer Address | * COVINGTON GA 30014 US |
| Baseline Brand Name | BARDEX MALECOT LATEX DRAIN |
| Baseline Generic Name | MALECOT DRAIN |
| Baseline Model No | NA |
| Baseline Catalog No | 086016 |
| Baseline ID | NA |
| Baseline Device Family | LATEX MALECOT DRAIN |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K910197 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-10-06 |