MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-19 for 10% NEUTRAL BUFFERED FORMALIN 594801 manufactured by Richard Allan Scientific Of Thermo Scientific.
[32221049]
Since (b)(6) 2014, there has been an increase in exposure to formalin due to container spills and leakage from the prefilled specimen containers. Leaking containers occur both on the initial handling of containers by the materials management staff as well as when resealing after the specimen has been added. The materials management team has communicated with the vendor and returned two specimen containers to the vendor for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058076 |
| MDR Report Key | 5249587 |
| Date Received | 2015-11-19 |
| Date of Report | 2015-11-19 |
| Date Added to Maude | 2015-11-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 10% NEUTRAL BUFFERED FORMALIN |
| Generic Name | 10% NEUTRAL BUFFERED FORMALIN |
| Product Code | IFP |
| Date Received | 2015-11-19 |
| Catalog Number | 594801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD ALLAN SCIENTIFIC OF THERMO SCIENTIFIC |
| Brand Name | UNK |
| Generic Name | CONTAINER |
| Product Code | MMK |
| Date Received | 2015-11-19 |
| Catalog Number | C4320-450B MNF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-19 |