MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for ACS CDEX31D manufactured by American Contract Systems.
[185223703]
Sterility issue, hair in sterile pack: cmc extremity pack opened on back table. Removed self-contained sterile splash basin pack to ring stand. Upon opening the sterile wrap enclosing the splash basin, saw a hair against the sidewall of the inner basin. Splash and contents not used; additional sterile supplies obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888212 |
| MDR Report Key | 9888212 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-12 |
| Report Date | 2020-03-23 |
| Date Reported to FDA | 2020-03-23 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| 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 | ACS |
| Generic Name | GENERAL SURGERY TRAY |
| Product Code | LRO |
| Date Received | 2020-03-27 |
| Model Number | CDEX31D |
| Lot Number | 955201 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN CONTRACT SYSTEMS |
| Manufacturer Address | 7300 W DETROIT ST CHANDLER AZ 85226 US 85226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |