MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-12-01 for CONTRAD 70 81911 manufactured by Beckman Coulter, Inc..
[2272085]
The customer reported that they observed a leak coming from a bottle of contrad 70. The leak was observed at a dealer facility. It is unknown as to whether personnel interfacing with the contrad 70 were wearing personal protective equipment however, there was no report of any personnel seeking medical attention associated with this event. No patient results were involved in this event. There was no modification to patient treatment associated with this event. There was no chemical/biohazardous exposure to personnel uncovered wounds or mucous membranes and no injuries were reported. The amount of leakage for this event could not be determined. Although the fluid volume of the contrad 70 container is theoretically significant enough to cause a slipping hazard if it is spilled, there were no reports of death or serious injury associated with this event. There was an exposure control plan in place at the facility and the material data safety sheets were reviewed.
Patient Sequence No: 1, Text Type: D, B5
[9491715]
Beckman coulter inc. Assessment of customer supplied photos revealed that there was no shipping damage to the affected bottle. No root cause could be determined for this event to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-05542 |
| MDR Report Key | 2355550 |
| Report Source | 01,08 |
| Date Received | 2011-12-01 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-11-04 |
| Date Mfgr Received | 2011-11-04 |
| Date Added to Maude | 2011-12-05 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTRAD 70 |
| Generic Name | DETERGENT |
| Product Code | JCB |
| Date Received | 2011-12-01 |
| Model Number | NA |
| Catalog Number | 81911 |
| Lot Number | 624224 |
| ID Number | NA |
| Operator | SERVICE AND TESTING PERSONNEL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-01 |