MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-27 for PNEUMO-MATIC INSUFFLATION NEEDLE 900-200 manufactured by Cooper Surgical.
[93046997]
Cooper surgical, pneumo-matic insufflation needle (14 gauge), did not pass occlusion test prior to use. The defective needle was removed from the field and exchanged for another "like" product that worked without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073559 |
| MDR Report Key | 7058947 |
| Date Received | 2017-11-27 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-11-21 |
| Date Added to Maude | 2017-11-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PNEUMO-MATIC INSUFFLATION NEEDLE |
| Generic Name | VARESS NEEDLE |
| Product Code | FHO |
| Date Received | 2017-11-27 |
| Model Number | 900-200 |
| Catalog Number | 900-200 |
| Lot Number | 225665 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-27 |