MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-12-17 for BACT/ALERT BPA CULTURE BOTTLE 279018 manufactured by Biomerieux, Inc..
[1036182]
The customer reported that a pt became ill after platelet transfusion. The platelets were cultured in the bact/alert bpa culture bottle. The bottle was unloaded as negative at 5 days, and sent for culture. The gram-stain culture was negative at 7 days. Platelets were sampled and the product was split into three donor bags. All three bags were administered to pts, but only one became ill with (b) (6). The unit from the ill pt was cultured and found positive for (b) (6). Bact/alert bpa culture bottles are used with the bact/alert microbial detection systems for quality control testing of leukocyte reduced apheresis platelet (lrap) units, and both leukocyte reduced single and pooled whole blood platelet concentrates (wbpc). Bact/alert bpa bottles support the growth of aerobic microorganisms (bacteria and fungi).
Patient Sequence No: 1, Text Type: D, B5
[8171682]
An investigation has been opened on this mdr. According to the customer, the bact/alert bpa culture bottle was negative after 5 days; the bottle indicator showed no change in color. The bact/alert bpa bottle was sent for culture, and the customer reported that the gram stain showed no organism, and that the culture was negative for growth. The package insert for the bact/alert bpa bottle cautions that "a report of 'negative' should not be interpreted as meaning that the original product is sterile. The negative status could be due to under-inoculation of the bottle, no organisms present in the inoculum, the number of organisms were too small for detection, or a culture bottle/medium that does not support the growth of the organism. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2008-00010 |
| MDR Report Key | 1290978 |
| Report Source | 05,06 |
| Date Received | 2008-12-17 |
| Date of Report | 2008-12-16 |
| Date of Event | 2008-12-04 |
| Date Mfgr Received | 2008-12-04 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2010-05-03 |
| 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 FRITZ |
| Manufacturer Street | 100 RODOLPHE ST |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202682 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT BPA CULTURE BOTTLE |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2008-12-17 |
| Catalog Number | 279018 |
| Lot Number | 1020911 |
| Device Expiration Date | 2009-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-17 |