FDA Adverse Event
Other
Summary report: N
PENCAN
MDR report key: 642261
·
Received October 19, 2005
Report
- Report Number
- 2523676-2005-00065
- Event Type
- Other
- Date Received
- October 19, 2005
- Date of Event
- September 16, 2005
- Report Date
- October 17, 2005
- Manufacturer
- B. BRAUN MEDICAL INC.
- Product Code
- BSP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A COMBINED SPINAL-EPIDURAL USED ON PT IN L&D, A HEALTHY BABY WAS DELIVERED. PT DEVELOPED BACTERIAL MENINGITIS AND IS IN ICU. THE FACILITY HAS REPORTED SEVEN DIFFERENT POSSIBLE LOTS FOR PENCAN SPINAL NEEDLE, P/N 333876: 60779208, MFG 6/9/2005 EXP: 5/30/2010; 60736865, MFG 2/10/2005 EXP: 1/30/2010; 60534154, MFG 4/15/2004 EXP: 3/30/2009; 60450359, MFG 5/29/2003 EXP: 4/30/2008; 60351376, MFG 7/22/2003 EXP: 6/30/2008; 60751397, MFG 3/21/2005 EXP: 2/28/2010; 60735964, MFG 11/24/2004 EXP: 10/30/2009 AND ONE KIT LOT NUMBER, P/N 33220: 60763503, MFG 7/29/2005, EXP: 6/30/2010. SEVERAL VOICE MAIL MESSAGES REQUESTING ADDITIONAL INFO WERE LEFT FOR THE REPORTER, HOWEVER, NO RETURN CALLS WERE RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENCAN | PENCIL POINT SPINAL NEEDLE | BSP | B. BRAUN MEDICAL INC. | NA | SEE B.5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |