MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-17 for TRYPTICASE SOY AGAR, 500ML BOTTLE 299099 manufactured by Becton Dickinson Gmbh.
[1430064]
This product is a 500ml bottle of agar that is melted then poured into plates or tubes. The technologists in the lab were using a microwave to melt the five bottles of media rather than a water bath. The bottles exploded in the microwave and three techs got hurt. One or more of the following treatments were provided to the individuals involved in this incident: x-rays, stitches, bandage to cover wounds, antibiotics and tylenol. No additional specific treatment information was provided.
Patient Sequence No: 1, Text Type: D, B5
[8751883]
This incident is the same event referenced in mdr report #1119779-2010-00005. There were two different products in the microwave when this incident occurred. Both media are labeled "for lab use only". This customer is an industrial testing laboratory that melts the agar in order to form plates/tubes of media for use in specimen testing. The customer also follows usp guidelines. The following is an excerpt from general information (non-mandatory) usp chapter 1117 good laboratory practices regarding the remelting of media: "remelting of an original container of solid media should be performed only once to avoid media whose quality is compromised by overheating or potential contamination. It is recommended that remelting be performed in a heated water bath or by using free-flowing steam. The use of microwave ovens and heating plates is common, but care should be taken to avoid damaging media by overheating and to avoid the potential injury to laboratory personnel from glass breakage and burns. The molten agar medium should be held in a monitored water bath at a temperature of 45 to 50 for not more than 8 hours. " although usp acknowledges the use of a microwave, bd does not recommend this. The following excerpt for handling this type of media appears in the (b)(4) manual, manual of microbiological culture media: "note: use of a microwave oven to melt tubed or bottled media is not recommended. " no corrective actions are planned at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2010-00004 |
| MDR Report Key | 1842588 |
| Report Source | 05 |
| Date Received | 2010-09-17 |
| Date of Report | 2010-09-16 |
| Date of Event | 2010-08-18 |
| Date Mfgr Received | 2010-08-18 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2010-10-01 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON DICKINSON GMBH |
| Manufacturer Street | TULLASTRASSE 8-12 |
| Manufacturer City | HEIDLEBERG 69126 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 69126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRYPTICASE SOY AGAR, 500ML BOTTLE |
| Product Code | JSG |
| Date Received | 2010-09-17 |
| Catalog Number | 299099 |
| Lot Number | 0117089 |
| Device Expiration Date | 2011-11-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON GMBH |
| Manufacturer Address | TULLASTRASSE 8-12 HEIDLEBERG 69126 GM 69126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-17 |