FDA Adverse Event
Other
Summary report: N
INTRADYN
MDR report key: 926723
·
Received March 29, 2007
Report
- Report Number
- 2243801-2007-00013
- Event Type
- Other
- Date Received
- March 29, 2007
- Date of Event
- December 27, 2006
- Report Date
- March 16, 2007
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- DYB
- PMA / PMN Number
- k0335227
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS DISCARDED AND IS NOT AVAILABLE FOR THE MFR TO EVALUATE, AND A LOT # WAS NOT REPORTED. WITHOUT THE SAMPLE AND A LOT # A THOROUGH EVAL COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE GUIDEWIRE MFR, LAKE REGION MEDICAL INC. FOR FURTHER INVESTIGATION. IF ANY INFO IS REC'D FROM LAKE REGION MEDICAL INC STATING THAT THERE IS AN INHERENT PROBLEM, THIS REPORT WILL BE RE-OPENED.
Description of Event or Problem · 1
AS REPORTED BY THE USER FACILITY: THE GUIDEWIRE WITH SHEATH UNRAVELED. ADD'L INFO PROVIDED BY THE USER FACILITY INDICATED THE PT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVAL. THE LOT # REMAINS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRADYN | PEDIATRIC ARTERIAL HEMO INTRODUCER | DYB | B. BRAUN MEDICAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |