FDA Adverse Event
Malfunction
Summary report: N
MAXZERO NEEDLELESS CONNECTOR
MDR report key: 7833203
·
Received August 30, 2018
Report
- Report Number
- 9616066-2018-01475
- Event Type
- Malfunction
- Date Received
- August 30, 2018
- Date of Event
- July 6, 2018
- Report Date
- August 5, 2018
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- UDI-DI
- 10885403230196
- PMA / PMN Number
- K132413
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCT; PRITUBING, MZ9226;MZ5306; 2N1191, THERAPY DATE (B)(6) 2018. 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
THE CUSTOMER REPORTED TUBING LEAKED ON A PATIENT WHO WAS ON TPN, INTRALIPIDS, AND PGE. THE CUSTOMER HAD PREVIOUSLY REPORTED THE (B)(4) IS TYPICALLY THE PRODUCT THAT LEAKS. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 676149 | MAXZERO NEEDLELESS CONNECTOR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | MZ1000-07 | 10885403230196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |