MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2007-03-14 for BARD TRANSURETHRAL INJECTION SYSTEM 65220 manufactured by C.r. Bard, Inc..
[16715825]
It was reported that a portion of the cannula with the metal needle attached, broke off from the remaining cannula during a transurethral injection procedure. The break in the cannula appears to have occurred beyond the metal portion of the needle. The cannula with the metal needle was immediately located and removed from the patient during the initial procedure. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[16907525]
One actual, partial sample was received and evaluated in a laboratory environment. The returned cannula measured 12 inches long and was found to have fractured at the tip end, where the metal needle is joined to the cannula. The end where the metal needle attaches was not returned for evaluation. The break area was at a rough 45 degree angle and was very jagged in appearance. The cannula did not appear to be embrittled. There were no stress marks on the cannula that would have indicated that the cannula had been kinked. The condition of the returned, partial sample appears to be related to post manufacturing damage as the product was verified to be intact prior to use. Without the remainder of the complaint sample being returned, further evaluation cannot be performed and the exact cause of the sample condition could not be determined. A review of the device history record showed the product was 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 received from the supplier showed the lot was manufactured, inspected, and packaged in accordance with the specification for the product. Basline report previously filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2007-00013 |
| MDR Report Key | 911769 |
| Report Source | 01 |
| Date Received | 2007-03-14 |
| Date of Report | 2007-03-14 |
| Date of Event | 2006-07-24 |
| Date Mfgr Received | 2007-02-13 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2007-09-14 |
| 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 | 2007-03-14 |
| Returned To Mfg | 2007-02-14 |
| Model Number | NA |
| Catalog Number | 65220 |
| Lot Number | 03HO2009 |
| ID Number | NA |
| Device Expiration Date | 2009-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 31 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 885327 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-14 |