FDA Adverse Event
Injury
Summary report: N
BD Q-SYTE LUER ACCESS SPLIT SEPTUM
MDR report key: 2355820
·
Received November 22, 2011
Report
- Report Number
- 9610847-2011-00090
- Event Type
- Injury
- Date Received
- November 22, 2011
- Date of Event
- October 4, 2011
- Report Date
- November 22, 2011
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FPA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL, HOWEVER, AN UNUSED, REPRESENTATIVE UNIT WILL BE RETURNED. ADDITIONAL INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE B. BRAUN 3-WAY-TAP CONNECTOR ATTACHED TO THE BD Q-SYTE DEVICE DETACHED, RESULTING IN LEAKAGE OF CYTOTOXIC CHEMOTHERAPY AGENTS ONTO THE RECEIVING PT, HIS/HER CLOTHES, HOSPITAL LINES AND FLOOR. THIS PUT THE STAFF AT SIGNIFICANT RISK OF EXPOSURE TO SAID CYTOTOXIC MATERIAL. ACCORDING TO THE ACCOUNT MANAGER, IT SEEMS AS THOUGH A FIRM CONNECT BETWEEN THE B. BRAUN DEVICE AND BD Q-SYTE DEVICE COULD NOT BE VISUALLY CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD Q-SYTE LUER ACCESS SPLIT SEPTUM | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 1055377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | CYTOTOXIC CHEMOTHERAPY AGENTS |