MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-21 for BLOOD COLLECTION DEVICE W/MALE LUER MBC6010 manufactured by Carefusion.
[139556194]
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. Additional patient information: diagnosis: esrd.
Patient Sequence No: 1, Text Type: N, H10
[139556195]
The customer reported that davita in-center staff have stated that while disconnecting the blood collection assembly with the male luer, the male luer threads are breaking off into the cannulation line. The staff had to use pliers to remove the broken pieces from the line. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616066-2019-00745 |
| MDR Report Key | 8441957 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-21 |
| Date of Report | 2019-02-28 |
| Device Manufacturer Date | 2018-07-05 |
| Date Added to Maude | 2019-03-21 |
| 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 | 2019-03-21 |
| Model Number | MBC6010 |
| Catalog Number | MBC6010 |
| 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 | 2019-03-21 |