MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-11 for PREFILLED FORMALIN CONTAINER 10001 manufactured by Path-tec.
[85637059]
Patient Sequence No: 1, Text Type: N, H10
[85637060]
Two prefilled formalin specimen cups were noted to be broken without any formalin in the cup. No patient specimen was placed in the cup. New specimen cup was retrieved and processed with no problem. Manufacturer response for speciment container, 40ml prefilled formalin container (per site reporter). Reported equipment failure to (b)(4), along with pictures. Path tec representative is investigating equipment failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6854744 |
| MDR Report Key | 6854744 |
| Date Received | 2017-09-11 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-06-06 |
| Report Date | 2017-07-28 |
| Date Reported to FDA | 2017-07-28 |
| Date Reported to Mfgr | 2017-07-28 |
| Date Added to Maude | 2017-09-11 |
| 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 |
| 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 | PREFILLED FORMALIN CONTAINER |
| Generic Name | URINE TRANSPORT KIT (EXCLUDES HIV TESTING) |
| Product Code | OHZ |
| Date Received | 2017-09-11 |
| Returned To Mfg | 2017-07-31 |
| Catalog Number | 10001 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PATH-TEC |
| Manufacturer Address | 5700 OLD BRIM RD MIDLAND GA 31820 US 31820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-11 |