FDA Adverse Event
Malfunction
Summary report: N
BLOOD COLLECTION DEVICE W/MALE LUER
MDR report key: 3904935
·
Received June 4, 2014
Report
- Report Number
- 9616066-2014-00518
- Event Type
- Malfunction
- Date Received
- June 4, 2014
- Report Date
- May 14, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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.
Description of Event or Problem · 1
CUSTOMER REPORTED THE MALE LUER ON THE BLOOD COLLECTION DEVICE IS ATTACHED TO THE PATIENT'S HEP LOCK (NEEDLE FREE CONNECTOR ON THE LOCK). UPON DISCONNECTION, THE MALE LUER ON THE BLOOD COLLECTION DEVICE BREAKS RESULTING IN A LEAK. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328091 | BLOOD COLLECTION DEVICE W/MALE LUER | COLLECTION DEVICE | FPA | CAREFUSION CORPORATION | MBC6010 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | MAXPLUS NEEDLE FREE CONNECTOR, MODEL/LOT: UNK |