MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-09-19 for CAMPBELL VENTRICULAR NEEDLE, 4", 12G 45-1065 manufactured by Johnson & Johnson Professionals, Inc..
[7762144]
The device was returned to jjpi, on 10/2/97 and forwarded to the new bedord mfg facility for analysis. The returned cannula was observed to be badly pitted around the nickel plated luer hub. Indicating the possiblity of exposure to harsh or corrosive chemicals. The area around the end of the tube where the tip was attached was examined throughly. A considerable amount of solder was present around the rim and on the inside diameter of the tube. It can not be determined whether or not there was enough solder material without the tip, and the tip was not returned. The product complaint file showed no other complaints reported on this product. Jjpi considers this file closed.
Patient Sequence No: 1, Text Type: N, H10
[18552957]
The pt under went a ventriculostomy. The tip of the needle was discovered missing after the physician had made his pass into the pt's ventricle. It was not known if the tip was there before making the pass, but was assumed to have been intact. After the case was completed, the pt was taken for a ct scan. The ct scan was negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1997-00145 |
| MDR Report Key | 121531 |
| Report Source | 05 |
| Date Received | 1997-09-19 |
| Date of Report | 1997-09-19 |
| Date of Event | 1997-08-21 |
| Date Mfgr Received | 1997-08-21 |
| Date Added to Maude | 1997-09-24 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAMPBELL VENTRICULAR NEEDLE, 4", 12G |
| Generic Name | CANNULA, VENTRICLE |
| Product Code | HCD |
| Date Received | 1997-09-19 |
| Returned To Mfg | 1997-10-02 |
| Model Number | NA |
| Catalog Number | 45-1065 |
| Lot Number | UNK |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 119042 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| Manufacturer Address | NEW BEDFORD INDUSTRIAL PARK NEW BEDFORD MA 02745 US |
| Baseline Brand Name | CAMPBELL VENTRICULAR NEEDLE, 4", 12G |
| Baseline Generic Name | CANNULA, VENTRICLE |
| Baseline Model No | NA |
| Baseline Catalog No | 45-1065 |
| Baseline ID | NI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-09-19 |