MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-10 for HEMOCCULT SENSA TEST FOR FECAL OCCULT BLOOD 64151 manufactured by Beckman Coulter, Inc..
[3063873]
The customer reported fluid leaked from the hemoccult sensa single slide with developer and applicators reagent bottle. Upon receipt, the customer observed white crystalline material around the bottle. The customer picked up the bottle and cleaned it with wet paper towel. The customer stated personal protective equipment (ppe) was not worn and rinsed hands thoroughly per labeling instructions. No injury was reported. The customer noted there was no damage to the bottle and it was half full. No patient samples were involved. A replacement reagent was sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
[10348773]
There is no indication the device was returned for evaluation. A definitive cause of the incident is unknown. Beckman coulter internal identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[10491771]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518658-2013-00001 |
| MDR Report Key | 2908926 |
| Report Source | 05,06 |
| Date Received | 2013-01-10 |
| Date of Report | 2012-12-13 |
| Date of Event | 2012-12-13 |
| Date Mfgr Received | 2013-01-11 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2013-04-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 606 ELMWOOD AVE. |
| Manufacturer City | SHARON HILL PA 19079103 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19079 1031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCCULT SENSA TEST FOR FECAL OCCULT BLOOD |
| Generic Name | REAGENT, OCCULT BLOOD |
| Product Code | KHE |
| Date Received | 2013-01-10 |
| Model Number | NA |
| Catalog Number | 64151 |
| Lot Number | 50411 |
| Device Expiration Date | 2014-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-10 |