MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-02 for ISOLATOR 1.5 ML MICROBIAL TUBES manufactured by .
[2202489]
Customer reported on (b)(6) 2011 that a blood culture tube shattered when inoculated with blood on (b)(6) 2011. Blood splattered over wall and 2 people. No other injuries to the 2 people involved due to shattering (glass did not puncture skin).
Patient Sequence No: 1, Text Type: D, B5
[9400734]
Lot 031422 was manufactured on 11/17/2010 and consisted of (b)(4). (b)(4). There was one defect noted for a broken tube during the assembly operation. No tubes were broken during the testing process. There were no internal rejects associated with this lot of production. Investigation: no samples were returned for investigation. The defect could not be confirmed. If a defect condition is detected, product would have been rejected and dispositioned appropriately. This is the only event of this nature for this lot.
Patient Sequence No: 1, Text Type: N, H10
[6348999]
Customer reported on (b)(6) 2011 that a blood culture tube shattered when inoculated with blood on (b)(6) 2011. Blood splattered over wall and 2 people. No other injuries to the 2 people involved due to shattering (glass did not puncture skin).
Patient Sequence No: 2, Text Type: D, B5
[14087099]
Lot 031422 was manufactured on 11/17/2010 and consisted of (b)(4). (b)(4). There was one defect noted for a broken tube during the assembly operation. No tubes were broken during the testing process. There were no internal rejects associated with this lot of production. Investigation: no samples were returned for investigation. The defect could not be confirmed. If a defect condition is detected, product would have been rejected and dispositioned appropriately. This is the only event of this nature for this lot.
Patient Sequence No: 2, Text Type: N, H10
| Report Number | 1221359-2011-00002 |
| MDR Report Key | 2214067 |
| Report Source | 07 |
| Date Received | 2011-08-02 |
| Date of Report | 2011-08-02 |
| Date of Event | 2011-06-28 |
| Date Mfgr Received | 2011-06-29 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2012-06-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMILY DEANE, SR. MGR. |
| Manufacturer Street | 10 SOUTHGATE RD. |
| Manufacturer City | SCARBOROUGH ME 04074 |
| Manufacturer Country | US |
| Manufacturer Postal | 04074 |
| Manufacturer Phone | 2077305750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLATOR 1.5 ML MICROBIAL TUBES |
| Generic Name | NONE |
| Product Code | LIO |
| Date Received | 2011-08-02 |
| Lot Number | 031422 |
| Device Expiration Date | 2012-10-31 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-02 |
| 2 | 0 | 1. Other | 2011-08-02 |