MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for RICHARD-ALLAN SCIENTIFIC PREFILLED 10% NEUTRAL BUFFERED FORMALIN CONTAINERS 51601 manufactured by Thermo Fischer Scientific.
[177979260]
Several 10% neutral buffered formalin specimen containers have been found to have leaked in transport of critical biopsy specimens. We have also noticed several leaking containers that have never been opened and re-secured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9676420 |
| MDR Report Key | 9676420 |
| Date Received | 2020-02-06 |
| Date of Report | 2019-11-11 |
| Date of Event | 2019-11-05 |
| Report Date | 2019-11-12 |
| Date Reported to FDA | 2019-11-12 |
| Date Reported to Mfgr | 2020-02-06 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | RICHARD-ALLAN SCIENTIFIC PREFILLED 10% NEUTRAL BUFFERED FORMALIN CONTAINERS |
| Generic Name | CONTAINER, SPECIMEN, STERILE |
| Product Code | FMH |
| Date Received | 2020-02-06 |
| Catalog Number | 51601 |
| Lot Number | 496728 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMO FISCHER SCIENTIFIC |
| Manufacturer Address | 75 PANORAMA CREEK DRIVE ROCHESTER NY 14625 US 14625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |