MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-31 for BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITA 221788 manufactured by Bd Diagnostic Systems.
[2941557]
Customer called to report that they have been having an ongoing contamination event with two liquid products from bd. The customer is seeing contamination with candida parapsilosis. They have been having this issue for several months without being able to track the source but did not provide specific dating. The common element is the use of bd thioglycollate broth and brain heart infusion broth. No contamination was seen on the gram stain or on the original media plates. The contamination was seen after the inoculation of the tubes. Customer's process is to inoculate the bhi, then inoculate the bhi suspension into the thioglycollate. The customer does not know the number of pts that were affected or specific lot numbers of product, but states that (b)(4) pts in total were affected throughout all of the lots. The affected specimens were primarily from sterile sites but the customer could not provide further details. The specimens were collected at the same facility in the operating room or er. The affected pts were initially treated with antifungal medication. No further pt info is available. These issues will be documented on mdrs 1119779-2012-00013 to 1119779-2012-00019.
Patient Sequence No: 1, Text Type: D, B5
[10302517]
The customer has evaluated the staff's specimen processing procedure and swabbed various areas of the lab, staff and operating room. He states that the staff's processing was within protocol and the contaminate did not grow from the environmental samples that he took. The customer incubated uninoculated vials and found no contamination evident. The customer also stated that they are reautoclaving the media and have not seen further contamination. Customer was made aware at this time that the media is not validated for additional autoclave cycles and may fail to function as intended. Customer also ruled out their sterile pipettes and swabs as possible sources. The batch history record was reviewed and all results are satisfactory and within normal ranges. No returns were sent by the customer. Retention samples were gram stained, wet prepped, incubated at 20-25c and 30-35c then subcultured to sabourad dextrose agar. No organisms were noted and no growth was observed to date. No trends have been noted to date in the lots reported by the customer. Mdrs were generated on each lot of media reported by this single customer as the customer was unable to distinguish which lot was used when a potential false result was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2012-00014 |
| MDR Report Key | 2826353 |
| Report Source | 05 |
| Date Received | 2012-10-31 |
| Date of Report | 2012-10-01 |
| Date of Event | 2012-10-01 |
| Date Mfgr Received | 2012-10-01 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2012-11-13 |
| 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 | GAIL CLAIBORNE |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164054 |
| Manufacturer G1 | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Street | 250 SCHILLING CIRCLE |
| Manufacturer City | COCKEYSVILLE MD 21030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21030 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITA |
| Product Code | JSG |
| Date Received | 2012-10-31 |
| Catalog Number | 221788 |
| Lot Number | 2052612 |
| Device Expiration Date | 2013-02-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Address | COCKEYSVILLE MD 21030 US 21030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-31 |