MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-11 for BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VIT 297292 manufactured by Bd Diagnostics.
[837172]
Customer called to report that about half of her box of 100 tubes were too tight and hard to get open. One of her lab assistance had a tube break in her hands upon trying to open it and cut her thumb requiring stitches.
Patient Sequence No: 1, Text Type: D, B5
[8029343]
Seven tubes from this lot were returned from the customer for investigation. Two tubes were opened by hand; one was easy to pen and the other was difficult. The remaining five tubes were tested for torque with readings from 4. 6 to 7. 6 in/lb. The satisfactory range is 3. 0-8. 0 in/lb with a target of 5. 5 in/lb. Additionally, the difficult to open tubes were measured for critical dimensions and found to be within spec. Retention samples were tested for ease to open and torque. Tubes were easily opened by a lab tech and the torque testing results were between 1. 3 to 5. 7 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 sys was conducted and show no other reported of this defect on this prod 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 | 1119779-2008-00004 |
| MDR Report Key | 1011985 |
| Report Source | 05 |
| Date Received | 2008-03-11 |
| Date of Report | 2008-03-10 |
| Date of Event | 2008-02-12 |
| Date Mfgr Received | 2008-02-12 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2008-08-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 211520999 |
| Manufacturer Country | US |
| Manufacturer Postal | 211520999 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 250 SCHILLIBNG CIR |
| 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, ENRICHED WITH VIT |
| Product Code | JSG |
| Date Received | 2008-03-11 |
| Returned To Mfg | 2008-02-18 |
| Catalog Number | 297292 |
| Lot Number | 7323024 |
| Device Expiration Date | 2008-11-11 |
| 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 | 1008540 |
| Manufacturer | BD DIAGNOSTICS |
| Manufacturer Address | 250 SCHILLING CIR. COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-11 |