MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-01 for BLOOD CULTURE KIT STANDARD 279102 manufactured by Biomerieux Inc..
[61592959]
A customer in the united states contacted biom? Rieux to report a blood sample exposure in association with a blood culture kit standard. The customer reported a nurse was drawing blood from a patient, with a history of fevers and (b)(6) status, into a blood culture bottle when the vacutainer needle slipped through the rubber hub. Blood dripped profusely through the needle. The nurse was able to remove the iv access that was connected to the vacutainer but some blood spilled on the floor and the nurse's shoes and pants. The nurse refused to be seen and denied transmission of blood into her eyes, mucous membrane or non-intact skin. The customer confirmed the needle as being bent and did not separate from the top of the hub. In addition, the butterfly did not separate from the luer connection at the top of the hub. There is no indication or report from the customer to biom? Rieux that this error led to any adverse event related to the nurse or patient's state of health. An internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[71856130]
A customer in the united states contacted biom? Rieux to report a blood sample exposure in association with a blood culture kit standard. The event did not impact or cause harm to the patient or customer as the bottle was successfully inoculated and the customer denies transmission of blood into her eyes, mucous membrane or non-intact skin. The product was not returned for evaluation as it was discarded. An investigation was conducted. The root cause could not be confirmed based on all available information. However, the most probable root cause was determined to be placing a smaller diameter vacuum tube into the holder at an angle that damaged the rubber boot covering the needle. When using vacuum tubes with small diameters use of an adapter of appropriate size is recommended. Caution should be exercised to ensure that the stopper is punctured centrally and that the tubes are not placed into the holder at an angle. Mishandling of the device may result in a contaminated needle stick , which may lead to transmission of infectious diseases. The process of injecting a specimen into culture bottles or vacuum tubes while the stopper is in place is not recommended. This can create positive pressure and result in specimen splattering from the tube which may cause exposure to blood borne pathogens, which may cause infectious disease. Any attempt to re-process the saf-t holder? For subsequent re-use may adversely affect the integrity of the saf-t holder? In performance. The manufacturer reported no irregularities were identified during the production process. The blood culture kit and saf-t holde? R instruction for use were reviewed and determined to provide sufficient caution and instruction to the user on proper handling technique. Great care must be taken to prevent sample exposure during inoculation into the culture bottles and vacutainers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00194 |
| MDR Report Key | 6138477 |
| Date Received | 2016-12-01 |
| Date of Report | 2017-04-05 |
| Date Mfgr Received | 2017-03-08 |
| Date Added to Maude | 2016-12-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOOD CULTURE KIT STANDARD |
| Generic Name | BLOOD CULTURE KIT STANDARD |
| Product Code | OFZ |
| Date Received | 2016-12-01 |
| Catalog Number | 279102 |
| Lot Number | 1608050026 |
| Device Expiration Date | 2017-04-08 |
| 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 | 595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-01 |