MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-16 for LIQUID UNASSAYED MULTIQUAL 699 manufactured by Bio-rad Laboratories.
[4956697]
Employee was reaching into the freezer to grab a jar of product. One of the jars had apparently shattered during shipment; however no staff were aware of this and the broken jar/glass had not been removed from the package. The employee did not visualize the package prior to reaching in, which resulted in a laceration to his right index finger when he contacted the broken glass. The employee washed the are with soap and water and sought medical attention for possible blood-bourne pathogen exposure counseling at a local clinic.
Patient Sequence No: 1, Text Type: D, B5
[12309828]
The labeling and certificate of analysis for liquid unassayed multiqual indicates that each human donor unit used to manufacture the product was tested by fda accepted methods and found (b)(6). In addition, the labeling instructs the users to treat all human source material as potentially infections and should be handled with the same precautions used with patient specimens.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016706-2014-00001 |
| MDR Report Key | 4009917 |
| Report Source | 07 |
| Date Received | 2014-07-16 |
| Date of Report | 2014-07-16 |
| Date of Event | 2014-06-19 |
| Date Mfgr Received | 2014-06-19 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2014-08-18 |
| 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 | ELIZABETH PLATT |
| Manufacturer Street | 9500 JERONIMO RD. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981285 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUID UNASSAYED MULTIQUAL |
| Generic Name | QUALITY CONTROL MATERIAL |
| Product Code | JJY |
| Date Received | 2014-07-16 |
| Model Number | NA |
| Catalog Number | 699 |
| Lot Number | 46463 |
| ID Number | +M235Q6992 |
| Device Expiration Date | 2014-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-16 |