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 2016-02-12 for BLOOD COLLECTION DEVICE W/MALE LUER MBC6010 manufactured by Carefusion.
[38217229]
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
[38217230]
Customer returned a document containing feedback from 3 nurses regarding recent vacutainer leaking events in the emergency department. This file pertains to the vacutainer failing to stop the flow of blood while changing tubes on a lab draw. There was no harm to the clinician or patient as a result of the leak.
Patient Sequence No: 1, Text Type: D, B5
[45228055]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616066-2016-00182 |
| MDR Report Key | 5435615 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-02-12 |
| Date of Report | 2016-01-18 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-02-12 |
| 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 | MS. SYLVIA VENTURA |
| 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 | 2016-02-12 |
| 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 | 2016-02-12 |