FDA Adverse Event
Malfunction
Summary report: N
AQUA SEAL CHEST DRAINAGE UNIT
MDR report key: 120901
·
Received September 18, 1997
Report
- Report Number
- 9611018-1997-00006
- Event Type
- Malfunction
- Date Received
- September 18, 1997
- Report Date
- August 12, 1997
- Manufacturer
- SHERWOOD MEDICAL INDUSTRIES
- Product Code
- KDQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL UNIT WAS RETURNED FOR EVAL. EVAL CONFIRMED REPORT AND FOUND THE FLOW CONTROL VALVE ON THE SUCTION INLET PORT WOULD NOT CLOSE SUFFICIENTLY. A REVIEW OF THE LOT HISTORY RECORDS FOUND NO RELATED DEFECTS. MFG HAS ADDED LINE CONTROLS TO ASSURE PROPER ASSEMBLY OF THE SUCTION CONTROL VALVE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE UNIT CONTINUED TO BUBBLE WHEN THE VALVE CLOSED. NO INJURY TO THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AQUA SEAL CHEST DRAINAGE UNIT | CHEST DRAINAGE SYSTEM | KDQ | SHERWOOD MEDICAL INDUSTRIES | NA | 97D214T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |