MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-29 for STERILCONTAINER S STER LOCKS PINK US910 manufactured by Aesculap Inc..
[143725609]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[143725610]
It was reported that there was an issue with the locks; they were not changing color correctly after sterilization of the container. Prior to surgery, locks on an instrument set were noted as having turned to white instead of blue. There was a short delay (15 minutes) while sterilization cycles and monitoring records were checked to validate sterility. There was no patient harm. The central sterile processing (csp) staff confirmed that new locks were stored in a black bag to avoid light contamination. Additional information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2019-00016 |
| MDR Report Key | 8562635 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-03 |
| Date Facility Aware | 2019-04-03 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-04-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 INC. |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILCONTAINER S STER LOCKS PINK |
| Generic Name | STERILE TECHNOLOGY |
| Product Code | FRG |
| Date Received | 2019-04-29 |
| Model Number | US910 |
| Catalog Number | US910 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC. |
| Manufacturer Address | 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-29 |