MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-08-31 for STEAM STER LOCKS ORANGE US906 manufactured by Aesculap Ag.
[84426933]
Manufacturing site investigation is on-going. Contract manufacturer (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[84426935]
Country of complaint: usa. It was reported on (b)(6)2017 that orange locks were processed and not changing from blue to dark brown/ black. The staff had to re-sterilize tray causing the delay. Discovered in central sterile. No patient harm reported. Surgical delay of 1 hour reported. Due to updated information provided on 31-aug-2017 there was an hour (1) delay in surgery and the patient was under anesthesia during delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2017-00022 |
| MDR Report Key | 6835976 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-08-31 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-01 |
| Date Facility Aware | 2017-08-31 |
| Date Mfgr Received | 2017-08-02 |
| Date Added to Maude | 2017-08-31 |
| 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 | 2017-08-31 |
| 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 | 2017-08-31 |