MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-23 for BLOOD COLLECTION DEVICE W/MALE LUER MBC6010 manufactured by Carefusion.
[22866633]
No product will be returned per customer. No investigation was performed. The root cause of this failure was not identified.
Patient Sequence No: 1, Text Type: N, H10
[22866634]
The customer reported a vacutainer septum became lodged in the rubber stopper of a blood culture bottle. There is no report of leakage or patient harm.
Patient Sequence No: 1, Text Type: D, B5
[45247194]
Correction on initial report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616066-2015-00922 |
| MDR Report Key | 4935547 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-07-07 |
| Date of Event | 2015-06-27 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2015-07-23 |
| 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. ADE AJIBADE |
| 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 | 2015-07-23 |
| 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 | 2015-07-23 |