FDA Adverse Event
Other
Summary report: N
GOODMAN CO. LTD
MDR report key: 911205
·
Received March 14, 2007
Report
- Report Number
- 2243801-2007-00010
- Event Type
- Other
- Date Received
- March 14, 2007
- Date of Event
- January 31, 2007
- Report Date
- March 8, 2007
- Manufacturer
- B. BRAUN MEDICAL INC.
- Product Code
- DYB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE IN THIS INCIDENT WAS RETURNED TO THE MFR TO BE EVALUATED. THE UNIT DID NOT PASS CONTINUITY TESTING. THE DEFECT WAS FOUND AT THE MANIFOLD. VISUAL INSPECTION OF THE UNIT INDICATES THAT THE UNIT WAS NOT PROPERLY SOLDERED INSIDE THE MANIFOLD. THE WIRES WERE NOT PROPERLY CONNECTED, THEREFORE ATTRIBUTING TO A SHORT CIRCUIT.
Description of Event or Problem · 1
PACING FAILURE - PACING OF THE JUGULAR VEIN WAS PERFORMED WITHOUT ISSUE. IT WAS THEN IMPLANTED. EVENING, PACING UNABLE TO BE PERFORMED. ANOTHER LOT WAS USED TO OVERCOME THE ISSUE. USED A TESTING DEVICE TO INVESTIGATE, AND DETERMINED THAT THERE IS A BREAK IN THE LEADS, PERHAPS NEAR THE LOCATION OF THE MANIFOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOODMAN CO. LTD | PACING CATHETER | DYB | B. BRAUN MEDICAL INC. | NA | 60873719 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |