D
Patient 1
CUSTOMER CALLED TO REPORT THAT CAPS ON THE MEDIA WERE TOO TIGHT. AN EMPLOYEE BROKE THE GLASS TUBE IN HER HAND WHILE ATTEMPTING TO OPEN IT. THE EMPLOYEE'S FINGER WAS CUT AND REQUIRED STITCHES. THE EMPLOYEE ALSO RECEIVED A TETANUS SHOT.
MAUDE MDR 1017141
- MDR report key
- 1017141
- Report number
- 1119779-2008-00005
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-02-25
- Date received
- 2008-03-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JOHN GERLICH
- Address
- 7 LOVETON CIRCLE SPARKS MD 21152 US
- Phone
- 410-410-4103
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BBL THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR | BD DIAGNOSTICS | JSG | 221798 | 7302935 | N | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-03-20 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE 97 TUBES FROM THIS LOT WERE RETURNED FROM THE CUSTOMER FOR INVESTIGATION. FIVE TUBES WERE OPENED EASILY BY HAND. TEN RANDOM TUBES WERE TESTED FOR TORQUE WITH READINGS FROM 3.4 TO 7.9 IN/LB. TWO OF THE TEN TUBES TESTED FOR TORQUE WERE UNABLE TO BE OPENED. AN ADDITIONAL 25 TUBES WERE TESTED FOR TORQUE AND SIX WERE HIGHER THAN 8 IN/LB. THE REMAINING 19 WERE WITHIN THE SATISFACTORY RANGE OF 3.0-8.0 IN/LB. ADDITIONALLY, THESE 25 TUBES WERE MEASURED FOR CRITICAL DIMENSIONS AND FOUND TO BE WITHIN SPECIFICATION. RETENTION SAMPLES WERE TESTED FOR EASE TO OPEN AND TORQUE. THREE TUBES WERE EASY TO OPEN AND TWO TUBES WERE VERY HARD TO OPEN. THE TORQUE TESTING RESULTS WERE BETWEEN 5.2 TO 8.0 IN/LB. THE BATCH HISTORY RECORD WAS EXAMINED AND FOUND TO BE SATISFACTORY WITH ALL TORQUE READINGS BETWEEN 4.5 AND 6.4 IN/LB DURING FILLING. A REVIEW OF THE COMPLAINT SYSTEM WAS CONDUCTED AND SHOW NO OTHER REPORTED OF THIS DEFECT ON THIS PRODUCT LOT. THIS LOT WILL BE MONITORED FOR FUTURE REPORTS OF THIS DEFECT. A CORRECTIVE ACTION HAS BEEN OPENED TO FURTHER ADDRESS THIS ISSUE.