MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2016-01-25 for BLOOD COLLECTION DEVICE W/MALE LUER MBC6010 manufactured by Carefusion.
[36804874]
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned. The root cause of this failure could not be identified.
Patient Sequence No: 1, Text Type: N, H10
[36804875]
Customer reported a generalized complaint regarding their blood collection devices that have occurred frequently over the past 2-3 months in the er. They state there is leaking from the 'gray stem' of the vacutainer onto both the patient and/or the clinician; there was no harm reported to either as a result of these events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616066-2016-00121 |
| MDR Report Key | 5389225 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2016-01-25 |
| Date of Report | 2016-01-07 |
| Date Mfgr Received | 2016-01-07 |
| Device Manufacturer Date | 2014-06-03 |
| Date Added to Maude | 2016-01-25 |
| 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-ASST |
| Product Code | KST |
| Date Received | 2016-01-25 |
| Model Number | MBC6010 |
| Catalog Number | MBC6010 |
| Lot Number | 140420 |
| Device Expiration Date | 2017-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-01-25 |