MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-01 for BBL THIOGLYCOLLATE MEDIUM WITH CALCIUM CARBO 298518 manufactured by Bd Microbiology Systems.
[804345]
A technician was attempting to unscrew the cap of a tube to inoculate the media with a specimen. The cap was tight and the technician broke the tube while trying to open it. The breakage resulted in a cut on the technician's hand which required stitches.
Patient Sequence No: 1, Text Type: D, B5
[7946669]
No returns were received for evaluation. Retention material from this lot of material was examined for tight caps. Examination with a thread kit found all material acceptable with no defects to the glass. Torque testing confirmed torque value above the initial release criteria. Manufacturing and release testing records were examined and found to be acceptable. Scheduled preventive maintenance is done on the torque machine and was current during manufacture of this lot of material. Root cause is suspected to be operator error. As corrective action, the complaint report was reviewed with the operators responsible for manufacturing this material. Retraining on proper torquing procedures occurred and has been documented. We will continue to monitor this issue for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2008-00002 |
| MDR Report Key | 991293 |
| Report Source | 05 |
| Date Received | 2008-02-01 |
| Date of Report | 2008-02-01 |
| Date of Event | 2008-01-04 |
| Date Mfgr Received | 2008-01-04 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2008-02-08 |
| 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 | BD MICROBIOLOGY SYSTEMS |
| Manufacturer Street | 2801 INDUSTRIAL DR. |
| Manufacturer City | MADISON WI 53713 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53713 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL THIOGLYCOLLATE MEDIUM WITH CALCIUM CARBO |
| Product Code | JSG |
| Date Received | 2008-02-01 |
| Catalog Number | 298518 |
| Lot Number | 7309612 |
| Device Expiration Date | 2008-11-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 960696 |
| Manufacturer | BD MICROBIOLOGY SYSTEMS |
| Manufacturer Address | 2801 INDUSTRIAL DR. MADISON WI 53713 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-02-01 |