MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-08 for BBL CRYSTAL ENTERIC/NONFERMENTER ID KIT 245000 manufactured by Bd Diagnostic Systems.
[3357409]
A staff member who had handled the kit inoculated a panel with a patient sample and contracted (b)(6) which resulted in hospitalization. She was a senior member of staff who was aware of the risks and hand washing etiquette etc. The lab states that when they got the crystal strip out of the hot room to read, that the plastic was wet and at the time thought it was condensation. The staff member has fully recovered. The hse have been into the laboratory following the riddor report and are satisfied with laboratory safety precautions. The hospital stated that the exact cause of the contamination could not be determined from their rca but was likely to be the crystal panel being contaminated.
Patient Sequence No: 1, Text Type: D, B5
[10632139]
No returns were received for investigation. Crystal kit bases and lids from retention sample were tested for leakage. No leakage was present. The complaint could not be confirmed. There are no trends for this type of issue. No action will be at this time and quality will continue to monitor complaints for this type of complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2013-00001 |
| MDR Report Key | 2999458 |
| Report Source | 05 |
| Date Received | 2013-03-08 |
| Date of Report | 2013-02-06 |
| Date of Event | 2013-02-06 |
| Date Mfgr Received | 2013-02-06 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-03-13 |
| 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 | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| 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 CRYSTAL ENTERIC/NONFERMENTER ID KIT |
| Product Code | JSS |
| Date Received | 2013-03-08 |
| Catalog Number | 245000 |
| Lot Number | 2212457 |
| Device Expiration Date | 2013-05-01 |
| 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. Hospitalization; 2. Other | 2013-03-08 |