MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-10-03 for CASE - 150ML SYRINGE W/HANDIFIL HANDIFIL STRAW 600269 manufactured by .
[16528342]
Product sample still in route from distributor. Once product has been received, an investigation will be performed and the appropriate follow up supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[16708060]
Distributor reports via e-mail that during incoming product inspection the following defect was discovered; "dust was found inside handifil straw". Search of this lot number and product id reveals no similar descriptions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-2007-00004 |
| MDR Report Key | 922586 |
| Report Source | 08 |
| Date Received | 2007-10-03 |
| Date of Report | 2007-09-04 |
| Date of Event | 2007-08-06 |
| Date Mfgr Received | 2007-09-04 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2007-11-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASE - 150ML SYRINGE W/HANDIFIL |
| Generic Name | HANDIFIL STRAW |
| Product Code | FCE |
| Date Received | 2007-10-03 |
| Model Number | HANDIFIL STRAW |
| Catalog Number | 600269 |
| Lot Number | 7145328 |
| ID Number | NA |
| Device Expiration Date | 2010-06-30 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 905992 |
| Manufacturer Address | TIJUANA, B.C. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-03 |