MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-12-18 for BARD CONTIGEN TRANSU INJECTION SYSTEM 652200 manufactured by C.r.bard, Inc..
[38259]
During a contigen procedure and after removing the cystoscope and the transurethral needle, the dr noted that the tip of the needle was missing. The dr re-entered with cystoscope and during grasping forceps, was able to retrieve the needle's tip from the injection site. No further complications were reported. No medwatch report filed by user facility.
Patient Sequence No: 1, Text Type: D, B5
[7768648]
Visual exam under 30x magnification verified break in cannula where it meets the plastic. A pc of cannula remainder inside the sheath & was bent to one side. The extreme bend may have resulted in fracture and eventual separation of the cannula. The defect most likely was a result of conditions most likely was a result of conditions encountered during in-use. No mfg deficiencies were found in the returned sample and the exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-1996-00018 |
| MDR Report Key | 58361 |
| Report Source | 05 |
| Date Received | 1996-12-18 |
| Date of Report | 1996-12-18 |
| Date of Event | 1996-11-26 |
| Date Facility Aware | 1996-11-26 |
| Date Mfgr Received | 1996-11-26 |
| Device Manufacturer Date | 1996-09-01 |
| Date Added to Maude | 1996-12-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD CONTIGEN TRANSU INJECTION SYSTEM |
| Generic Name | TRANSURETHRAL NEEDLE |
| Product Code | LMI |
| Date Received | 1996-12-18 |
| Model Number | NA |
| Catalog Number | 652200 |
| Lot Number | 031G2788 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 58818 |
| Manufacturer | C.R.BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30209 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 | 1996-12-18 |