FDA Adverse Event
Malfunction
Summary report: N
TRANSFER SET
MDR report key: 2971544
·
Received February 1, 2013
Report
- Report Number
- 1518293-2013-00035
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- July 26, 2012
- Report Date
- February 1, 2013
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- DXT
- PMA / PMN Number
- K042744
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
COVIDIEN (B)(4) RA/QA REPORTS; INCIDENT WITH A SALINE TRANSFER SET AT (B)(4) (NO PATIENTS ARE INVOLVED) BUT THEY ARE CLAIMING THAT AFTER FILLING AN EMPTY SYRINGE FROM THE SALINE BAG THAT A SIGNIFICANT AMOUNT OF LIQUID HAS DRIPPED INTO THE INJECTOR AND AS A RESULT CAUSE THE UNIT TO STOP WORKING. NO REPORTED INJURY. USUALLY THERE IS VERY LITTLE SOLUTION DRIP AFTER DISCONNECTION. ON (B)(6) 2013: INVESTIGATION OF THE DEFECTIVE TUBING FOUND CAUSE WAS DUE TO DEBRIS IN THE AREA THAT COULD HAVE INTERFERED WITH A GOOD VALVE SEAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45262 | TRANSFER SET | 74D-XT | DXT | LIEBEL-FLARSHEIM CO. | TRANSFER SET | 2082927 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |