FDA Adverse Event
Injury
Summary report: N
ALARIS SYRINGE MODULE ADMINISTRATION SET
MDR report key: 3161981
·
Received May 29, 2013
Report
- Report Number
- 9616066-2013-00376
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- May 7, 2013
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K811885
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, THE PRODUCT HAS NOT BEEN RECEIVED FOR EVAL. A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE PRODUCT BE RECEIVED FOR EVAL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE FEMALE LUER ON THE SYRINGE SET CRACKED AND LEAKED. THE CLINICIAN HAD TO REMOVE AND REPLACE THE PT'S CVC LINE. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234342 | ALARIS SYRINGE MODULE ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 10014914 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | SYRINGE: MFR, MODEL, LOT NUMBER UNK| ALARIS PC UNIT: SN UNK| ALARIS SYRINGE MODULE: SN UNK| CVC LINE: MFR, MODEL, LOT NUMBER UNK |