MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-11-03 for INSUFFLATION/ACCESS NEEDLE 14 GAUGE S100000 manufactured by Ponce- Uss.
[590629]
Reportedly, the top of the insufflation access needle sheared off upon insertion. The surgeon opened a new needle and continued. No pt injury was reported. Procedure: tubal ligation.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2647580-2004-00502 |
MDR Report Key | 823036 |
Report Source | 06 |
Date Received | 2004-11-03 |
Date of Report | 2004-01-07 |
Date of Event | 2003-12-18 |
Date Mfgr Received | 2004-01-07 |
Device Manufacturer Date | 2003-09-01 |
Date Added to Maude | 2007-03-06 |
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 | 0 |
Manufacturer Contact | JEFF DEMING |
Manufacturer Street | 195 MCDERMOTT RD. |
Manufacturer City | NORTH HAVEN CT 06473 |
Manufacturer Country | US |
Manufacturer Postal | 06473 |
Manufacturer Phone | 2034926049 |
Manufacturer G1 | PONCE - USS |
Manufacturer Street | SABANETAS INDUSTRIAL PARK |
Manufacturer City | MERCEDITA PR 00715 |
Manufacturer Country | US |
Manufacturer Postal Code | 00715 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | INSUFFLATION/ACCESS NEEDLE 14 GAUGE |
Generic Name | ACCESS NEEDLE |
Product Code | FHO |
Date Received | 2004-11-03 |
Returned To Mfg | 2004-01-15 |
Model Number | NA |
Catalog Number | S100000 |
Lot Number | P3J405 |
ID Number | * |
Device Expiration Date | 2008-10-31 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 810444 |
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 | 2004-11-03 |