MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-01-26 for BARD TRANSURETHRAL INJECTION SYSTEM 652200 manufactured by C.r. Bard, Inc..
[20352138]
It was reported that during an injection of a urethral bulking implant in 2006, the needle broke on the plastic sheath outside of the patient's body during the procedure. No patient injury or further complications were reported. The complaint sample was discarded. This needle is not indicated for use with this bulking material.
Patient Sequence No: 1, Text Type: D, B5
[20403394]
No sample or lot number information was provided for evaluation. The doctor was using the bulking implant off-label as the instructions for use of the implant material state the injection method requires the use of needles specified in the labeling. The needle being used was not one of those specified for use with this bulking material. The raw materials used in the implant material is known to cause degradation to needles comprised of polyurethane such as the one used in this procedure. The investigation concluded the most probable cause of this event was the user failed to follow labeling indications and used the product off-label. Baseline reported previously filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2006-00232 |
| MDR Report Key | 812380 |
| Report Source | 00 |
| Date Received | 2007-01-26 |
| Date of Report | 2007-01-26 |
| Date of Event | 2006-12-19 |
| Date Facility Aware | 2006-12-19 |
| Date Mfgr Received | 2006-12-29 |
| Date Added to Maude | 2007-02-07 |
| 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 | VIVIAN STEPHENS, MANAGER |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846902 |
| Manufacturer G1 | C.R. BARD, INC. |
| 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 | BARD TRANSURETHRAL INJECTION SYSTEM |
| Generic Name | TRANSURETHRAL INJECTION SYSTEM |
| Product Code | LMI |
| Date Received | 2007-01-26 |
| Model Number | NA |
| Catalog Number | 652200 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 799864 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Baseline Brand Name | BARD CONTIGEN TRANSURETHRAL INJECTION SYSTEM |
| Baseline Generic Name | TRANSURETHRAL NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 652200 |
| Baseline ID | NA |
| Baseline Device Family | CONTIGEN TRANSURETHRAL INJECTION SYSTEM |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | Y |
| Premarket Approval | P9000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-01-26 |