MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for BD SLIDEPREP PROCESSOR manufactured by Becton Dickinson And Co..
[87496369]
In (b)(6) 2016, i filed complaint number (b)(4) regarding the bd prepstain processor for surepath pap smears causing cross-contamination/transfer of one patients cells onto another patient's pap smear. Bd's response was to develop a new instrument called the slideprep. We have now identified 2 instances of cross-contamination and 14 of artifact on the slideprep instrument. Please contact me as soon as possible. Dr. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072422 |
| MDR Report Key | 6893937 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-09-19 |
| Date Added to Maude | 2017-09-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD SLIDEPREP PROCESSOR |
| Generic Name | BD SLIDEPREP PROCESSOR |
| Product Code | MKQ |
| Date Received | 2017-09-25 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-25 |