MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-03-29 for BLOOD COLLECTION DEVICE W/MALE LUER MBC6000 manufactured by Carefusion.
[41416939]
No product will be returned per customer. The customer complaint could not be confirmed because the product was not sequestered for failure investigation. The root cause of this failure was not identified.
Patient Sequence No: 1, Text Type: N, H10
[41416940]
The customer states that the blood collection assembly tip covering the transfer needle was dislodged during the transfer process, not allowing blood culture specimen to be used.
Patient Sequence No: 1, Text Type: D, B5
[45235000]
Patient Sequence No: 1, Text Type: N, H10
[53692946]
The customer? S report of the rubber sheath separating was confirmed. Visual inspection of the device revealed that the synthetic rubber sheath was missing. No other damages were found on the blood collection device. Functional testing was not performed due to the obvious damage. The root cause of the synthetic rubber sheath dislodging from the needle was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616066-2016-00499 |
| MDR Report Key | 5533492 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-22 |
| Date of Event | 2016-03-22 |
| Date Mfgr Received | 2016-07-21 |
| Date Added to Maude | 2016-03-29 |
| 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 | BLOOD SET |
| Product Code | KST |
| Date Received | 2016-03-29 |
| Returned To Mfg | 2016-07-18 |
| Model Number | MBC6000 |
| Catalog Number | MBC6000 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-03-29 |