MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-24 for DIFCO DESOXYCHOLATE AGAR 227310 manufactured by Bd Diagnostic Systems.
[1804605]
An employee was attempting to make this media in a tightly capped erlenmeyer flask. While heating, the employee was distracted and forgot to loosen the cap. The flask shattered and glass shards cut the employee. The wound required stitches. The contact stated that in the future, the cap will be vented or loosened prior to applying heat.
Patient Sequence No: 1, Text Type: D, B5
[8797833]
Desoxycholate agar requires rehydration from dehydrated culture media. Directions to prepare the agar are to blend the required amount of powder and water. Mixing thoroughly. Heat with frequent agitation and boil for 1 minute to completely dissolve the powder. Avoid overheating and do not autoclave. It is standard laboratory practice for the preparation of media to ensure that flasks being heated are properly vented. If heating continues and the pressure is not adequately relieved, the pressure and temperature can rise to a point that the flask may burst. In this instance, the customer admits to improperly venting the container while heating. No further action will be taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2010-00007 |
| MDR Report Key | 1911508 |
| Report Source | 05 |
| Date Received | 2010-11-24 |
| Date of Report | 2010-11-23 |
| Date of Event | 2010-10-28 |
| Date Mfgr Received | 2010-10-28 |
| Date Added to Maude | 2011-04-08 |
| 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 | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 39 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIFCO DESOXYCHOLATE AGAR |
| Product Code | JSG |
| Date Received | 2010-11-24 |
| Catalog Number | 227310 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Address | 39 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-11-24 |