MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-20 for BBL THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR 221798 manufactured by Bd Diagnostics.
[836854]
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.
Patient Sequence No: 1, Text Type: D, B5
[8051110]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2008-00005 |
| MDR Report Key | 1017141 |
| Report Source | 05 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-03-21 |
| Date of Event | 2008-02-25 |
| Date Mfgr Received | 2008-02-25 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2008-09-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 250 SCHILLING CIRCLE |
| Manufacturer City | COCKEYSVILLE MD 21030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21030 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR |
| Product Code | JSG |
| Date Received | 2008-03-20 |
| Returned To Mfg | 2008-02-28 |
| Catalog Number | 221798 |
| Lot Number | 7302935 |
| Device Expiration Date | 2008-10-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1015337 |
| Manufacturer | BD DIAGNOSTICS |
| Manufacturer Address | 250 SCHILLING CIRCLE COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-20 |