FDA Adverse Event
Malfunction
Summary report: N
NDEHP 2CLV YSTE MACR
MDR report key: 3111743
·
Received May 7, 2013
Report
- Report Number
- 9613251-2013-00130
- Event Type
- Malfunction
- Date Received
- May 7, 2013
- Date of Event
- April 9, 2013
- Report Date
- April 10, 2013
- Manufacturer
- HOSPIRA, LTD
- Product Code
- FPA
- PMA / PMN Number
- K101677
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED PARTICULATE. THE TUBING SET WAS BEING USED TO DELIVER 1000 ML RINGERS LACTATE, AT AN UNSPECIFIED RATE, VIA GRAVITY. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED A SMALL BLACK PARTICLE WAS NOTED IN THE DRIP CHAMBER OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198173 | NDEHP 2CLV YSTE MACR | 80FPA | FPA | HOSPIRA, LTD | NA | 220024W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | LACTATED RINGER'S INJECTION, LIST #07953, LOT #UNK |