MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-02-10 for NONE manufactured by .
[1960943]
.
Patient Sequence No: 1, Text Type: D, B5
[8949243]
Upon eval of the returned sample, evidence was found that the glue that bonds the tubing to the green blow-by connector had not fully cured when the tubing was coiled, and the uncured glue came into contact with a section of the tube. Once the glue cured, the connector became bonded to another section of tubing unintentionally.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246980-2011-00001 |
| MDR Report Key | 1999131 |
| Report Source | 99 |
| Date Received | 2011-02-10 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2011-05-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | BSJ |
| Date Received | 2011-02-10 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-10 |