MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-09-20 for INSUFFLATION/ACCESS NEEDLE 14G S100000 manufactured by Ponce - Uss.
[268327]
Procedure: laparoscopy (non-specific). Reportedly, the surgeon inserted the needle and the needle broke at the white plastic area (hub). The surgeon located and removed the needle from the cavity. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2002-00196 |
| MDR Report Key | 418460 |
| Report Source | 05,06 |
| Date Received | 2002-09-20 |
| Date of Report | 2002-08-20 |
| Date of Event | 2002-08-20 |
| Date Mfgr Received | 2002-08-20 |
| Device Manufacturer Date | 2002-05-01 |
| Date Added to Maude | 2002-09-27 |
| 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 |
| Manufacturer Contact | LAURA SOUSA, RN, MA |
| Manufacturer Street | 195 MCDERMOTT RD. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926334 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSUFFLATION/ACCESS NEEDLE 14G |
| Generic Name | SURGICAL ACCESS NEEDLE |
| Product Code | FHO |
| Date Received | 2002-09-20 |
| Model Number | NA |
| Catalog Number | S100000 |
| Lot Number | P2E127 |
| ID Number | NA |
| Device Expiration Date | 2007-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 407499 |
| Manufacturer | PONCE - USS |
| Manufacturer Address | SABANETAS INDUSTRIAL PARK MERCEDITA PR 00715 US |
| Baseline Brand Name | INSUFFLATION/ACCESS NEEDLE 14G |
| Baseline Generic Name | SURGICAL ACCESS NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | S100000 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-09-20 |