FDA Adverse Event
Malfunction
Summary report: N
HUDSON ISO-GARD FILTER STR. STERILE
MDR report key: 3193096
·
Received June 21, 2013
Report
- Report Number
- 8040412-2013-00110
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 27, 2013
- Report Date
- May 29, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS RETURNED FOR EVAL, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE DEVICE SPLITS INTO TWO SEPARATE PARTS WHEN GIVEN A SMALL PULL-APART FORCE. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282781 | HUDSON ISO-GARD FILTER STR. STERILE | ISO-GARD FILTER | CAH | TELEFLEX MEDICAL | 13AT08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |