MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-10-30 for 36 KHZ MAN1 TUBING SET C3601 manufactured by Valley Lab.
[16009125]
It has been reported that the tubing leaked during surgery at one of the connection sites along the tubing line. No pt injury has been reported. As reported, no revision or medical intervention was needed.
Patient Sequence No: 1, Text Type: D, B5
[16574493]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported information. The mfr has been notified of the reported incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2007-00499 |
| MDR Report Key | 2954137 |
| Report Source | 05,06 |
| Date Received | 2007-10-30 |
| Date of Report | 2007-10-30 |
| Date Mfgr Received | 2007-10-02 |
| Date Added to Maude | 2013-02-12 |
| 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 | LINDA GOLDSTEIN |
| Manufacturer Street | 311C ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362269 |
| Manufacturer G1 | VALLEY LAB |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 36 KHZ MAN1 TUBING SET |
| Generic Name | NONE |
| Product Code | LBK |
| Date Received | 2007-10-30 |
| Catalog Number | C3601 |
| Lot Number | 7068062 |
| Device Expiration Date | 2012-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VALLEY LAB |
| Manufacturer Address | BOULDER CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-30 |