MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-02-15 for BLOOD COLLECTION DEVICE W/MALE LUER MBC6010 manufactured by Carefusion.
[38219892]
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[38219893]
Customer returned a document containing feedback from 3 nurses regarding recent vacutainer leaking events in the emergency department. This file pertains to the vacutainer continuing to leak after the blood tube was withdrawn from the device until the vacutainer was completely removed. There was no harm to the clinician or patient as a result of the leak.
Patient Sequence No: 1, Text Type: D, B5
[45237221]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616066-2016-00183 |
| MDR Report Key | 5436262 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-02-15 |
| Date of Report | 2016-01-18 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-02-15 |
| 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 | MR. STEPHEN BILELLO |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214386 |
| Manufacturer Phone | 8586172000 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 921214386 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOOD COLLECTION DEVICE W/MALE LUER |
| Generic Name | SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL |
| Product Code | KST |
| Date Received | 2016-02-15 |
| Model Number | MBC6010 |
| Catalog Number | MBC6010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 10020 PACIFIC MESA BLVD SAN DIEGO CA 921214386 US 921214386 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-15 |