MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-04-13 for ANDERSON AN10-S (AN10.11) manufactured by Andersen Products.
[15026237]
Pt was incubated with an an10. 11 and the tube started to leak around the molded plastic connector. The tube was removed. Another tube from the same lot was incubated and the same problem occurred and that tube was also removed. No harm was caused to the pt.
Patient Sequence No: 1, Text Type: D, B5
[15272566]
All tubes mfg in this lot (290208) were 100% inspected for leak testing. It is unk why the two tubes leaked and the results could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1053825-2010-00002 |
| MDR Report Key | 2823664 |
| Report Source | 06 |
| Date Received | 2010-04-13 |
| Date of Report | 2010-04-13 |
| Date of Event | 2010-03-14 |
| Date Facility Aware | 2010-03-14 |
| Report Date | 2010-04-13 |
| Date Reported to FDA | 2010-04-13 |
| Date Reported to Mfgr | 2010-03-14 |
| Date Mfgr Received | 2010-03-14 |
| Device Manufacturer Date | 2009-12-04 |
| Date Added to Maude | 2012-11-09 |
| 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 | 3 |
| Manufacturer Street | 3202 CAROLINE DR., HEALTH SCIENCE PARK |
| Manufacturer City | HAW RIVER NC 27258 |
| Manufacturer Country | US |
| Manufacturer Postal | 27258 |
| Manufacturer Phone | 3363763000 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANDERSON AN10-S (AN10.11) |
| Generic Name | AN10-S |
| Product Code | BSS |
| Date Received | 2010-04-13 |
| Model Number | AN10-S |
| Catalog Number | AN10.11 |
| Lot Number | 290208 |
| ID Number | NA |
| Device Expiration Date | 2014-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANDERSEN PRODUCTS |
| Manufacturer Address | HAW RIVER NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-13 |