MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-26 for STEAM STER LOCKS ORANGE US906 manufactured by Aesculap Ag.
[50512899]
Manufacturing site investigation is on-going. Contract manufacturer: (b)(4). Pma 510(k): k890764.
Patient Sequence No: 1, Text Type: N, H10
[50512900]
Country of complaint: usa. Customer reported that following processing of steril containers it was observed that the orange locks dots are changing back to blue. The customer stated that this caused a delay in several surgeries because they had to reprocess sets again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00642 |
| MDR Report Key | 5824082 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-26 |
| Date of Report | 2016-07-26 |
| Date of Event | 2016-06-20 |
| Date Facility Aware | 2016-06-21 |
| Date Mfgr Received | 2016-06-27 |
| Date Added to Maude | 2016-07-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEAM STER LOCKS ORANGE |
| Generic Name | PROCESS INDICATOR LOCK |
| Product Code | KCT |
| Date Received | 2016-07-26 |
| Model Number | US906 |
| Catalog Number | US906 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-26 |