FDA Adverse Event
Malfunction
Summary report: N
NDHP LS MICROB CLAVE
MDR report key: 3061470
·
Received April 10, 2013
Report
- Report Number
- 9613251-2013-00101
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- January 1, 2013
- Report Date
- January 14, 2013
- Manufacturer
- HOSPIRA LTD.
- Product Code
- FPA
- PMA / PMN Number
- K101677
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE DEPRESSED POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148245 | NDHP LS MICROB CLAVE | 80FPA | FPA | HOSPIRA LTD. | NA | UNK4W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |