MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-13 for BARD TRANSURETHRAL INJECTION SYSTEM 652200 manufactured by C.r. Bard, Inc..
[18907818]
One actual sample was rec'd and evaluated in a laboratory environment. The sheath was rec'd in two pieces and was noted to have broken at the hub end of the metal needle. 10/16 of an inch of sheath was remaining on the metal needle. It appears the sheath was bent/kinked where the metal needle ends and subsequently fractured at that juncture. The plastic sheath material is polycarbonate and the stainless steel needle is welded into the sheath tubing. The sheath broke at the point where the needle ended. There were no manufacturing defects found in the returned, actual sample. It is possible that the needle encountered resistance at the injection site and the dr subsequently continued to push against the resistance resulting in the sheath breaking at this juncture. The exact cause of the sample condition could not be determined. A review of the device history record showed that product manufactured under the reported lot number passed all inspections with no rejections noted. A review of the subassembly components showed they all passed incoming inspections and qualifications. The certificate of compliance rec'd from he supplier showed the lot was manufactured, inspected, and packaged in accordance with the specification for the product.
Patient Sequence No: 1, Text Type: N, H10
[19053999]
It was reported that during a transurethral injection of a urethral bulking implant, the needle tip broke off and remained inside the pt. The dr used biopsy forceps and retrieved the needle tip during the initial procedure. No pt injury or further complications were reported. Additional info has been requested, but has nto been rec'd.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2006-00193 |
| MDR Report Key | 785248 |
| Report Source | 06 |
| Date Received | 2006-11-13 |
| Date of Report | 2006-11-13 |
| Date Mfgr Received | 2006-10-13 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-11-22 |
| 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 | 2006-11-13 |
| Returned To Mfg | 2006-10-19 |
| Model Number | NA |
| Catalog Number | 652200 |
| Lot Number | CVQD0011 |
| ID Number | NA |
| Device Expiration Date | 2011-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 773044 |
| 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 | 2006-11-13 |