MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-08-23 for BARD TEGRESS TRANSURETHRAL STAINLESS INJECTION NEEDLE 653300 manufactured by C.r. Bard, Inc..
[526796]
It was reported that when the doctor was performing a urethral implant procedure on a male patient who had a lot scar tissue and upon attempting the third injection, he was unable to inject the bulking material. The dr advanced the injection needle further in order to get past the scar tissue, and he was then able to inject the material. Under fluoroscopy, the doctor noted that the tip of the injection needle was missing. He removed the remainder of the needle from the patient and observed that approximately 2mm of the needle tip was missing. He detached the needle from the syringe and the nurse discarded it. The nurse opened another needle to use in order to complete the procedure. The doctor believes that the tip of the needle remains within the bulk of the implanted material inside of the patient. He is not going to remove it at this time. No further complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
[7795988]
No sample was returned for evaluation. A review of the device history record (dhr) found nothing to indicate this type of problem. The product met all required specifications. A review of component dhr determined that all needle measurements: needle tip id and tubing id, tip length, needle od were certified by the supplier as within specification. Visual inspection by iqc determined 80 units were inspected under 2x - 3x magnification and passed inspection with no defects noted. A review of the complaint history showed no other events of this type having been reported for this product. While no exact conclusions can be made without a sample to evaluate, it is believed that the needle tip may have become damaged when trying to penetrate the scar tissue on the third attempt to injecting the implant material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2006-00144 |
| MDR Report Key | 770769 |
| Report Source | 07 |
| Date Received | 2006-08-23 |
| Date of Report | 2006-08-23 |
| Date Mfgr Received | 2006-07-25 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-10-20 |
| 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 |
| 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 TEGRESS TRANSURETHRAL STAINLESS INJECTION NEEDLE |
| Generic Name | TEGRESS TRANSURETHRAL INJECTION NEEDLE |
| Product Code | LMI |
| Date Received | 2006-08-23 |
| Model Number | NA |
| Catalog Number | 653300 |
| Lot Number | CVQA0018 |
| ID Number | NA |
| Device Expiration Date | 2008-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 758570 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Baseline Brand Name | BARD TEGRESS TRANSURETHRAL STAINLESS INJECTION NEEDLE |
| Baseline Generic Name | TEGRESS TRANSURETHRAL INJECTION NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 653300 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-08-23 |