MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-04-21 for BACTEC PEDS PLUS/F BLOOD CULTURE MEDIUM * 442194 manufactured by Bd Diagnostic Systems, Bd Caribe, Ltd..
[446212]
Hosp had transported bactec blood culture bottle in their pneumatic tube system. When the carrier was opened, the bactec bottle had broken and the contents leaked into the carrier. A health proffesional in the pharmacy was exposed to the blood in the carrier. There was no injury, just exposure. The specimen was from a pt who was positive for hepatitis c. Gamma globulin was administered to the person in the pharmacy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2006-00002 |
| MDR Report Key | 705072 |
| Report Source | 05 |
| Date Received | 2006-04-21 |
| Date of Report | 2006-04-20 |
| Date of Event | 2006-03-21 |
| Date Mfgr Received | 2006-03-21 |
| Date Added to Maude | 2006-05-01 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC PEDS PLUS/F BLOOD CULTURE MEDIUM |
| Generic Name | BLOOD CULTURE MEDIUM |
| Product Code | JTA |
| Date Received | 2006-04-21 |
| Model Number | * |
| Catalog Number | 442194 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 694140 |
| Manufacturer | BD DIAGNOSTIC SYSTEMS, BD CARIBE, LTD. |
| Manufacturer Address | * CAYEY PR * US |
| Baseline Brand Name | BACTEC PEDS PLUS/F CULTURE MEDIUM |
| Baseline Generic Name | BLOOD CULTURE MEDIUM |
| Baseline Model No | NA |
| Baseline Catalog No | 442194 |
| Baseline ID | LOT# 4324535 |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 9 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K954927 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-21 |