FDA Adverse Event
Malfunction
Summary report: N
NDHP PPB 101 CLV BKC
MDR report key: 3040228
·
Received April 3, 2013
Report
- Report Number
- 9613251-2013-00095
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- December 17, 2012
- Report Date
- January 28, 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
DURING TESTING, SOLUTION LEAKED AT THE CONNECTION OF THE TUBING TO THE LEG OF THE PROXIMAL CLAVE Y-SITE. TESTING FOUND SMALL GAPS BETWEEN THE TUBING AND LEG OF THE CLAVE Y-SITE. THIS WAS DUE TO EXCESS SOLVENT THAT WEAKENED THE TUBING RESULTING IN THE FORMATION OF THE SMALL GAPS. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, SOLUTION LEAKED AT THE CONNECTION OF THE TUBING TO THE LEG OF THE PROXIMAL CLAVE Y-SITE OF THE TUBING SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136855 | NDHP PPB 101 CLV BKC | 80FPA | FPA | HOSPIRA LTD. | NA | 200804W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |