MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-27 for STEAM STER LOCKS ORANGE US906 manufactured by B.braun Surgical Sa.
[58602205]
Manufacturing site evaluation: evaluation on-going. Additional information: contract manufacturer lot number is not provided, it is unknown who contract manufacturer of these locks could be: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58602206]
Country of complaint: usa it was reported that while in the operating room setting up the sterile room pre-op, the organge lock shattered when opening on the sterile field. The a part of the lock landed on a sterile set. A new instrument tray was retrieved. There was a 15 minute delay in surgery. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00939 |
| MDR Report Key | 6062011 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-27 |
| Date of Report | 2016-10-27 |
| Date Facility Aware | 2016-09-28 |
| Date Mfgr Received | 2016-09-27 |
| Date Added to Maude | 2016-10-27 |
| 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 | B.BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, BARCELONA 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEAM STER LOCKS ORANGE |
| Generic Name | STERILE TECHNOLOGY |
| Product Code | KCT |
| Date Received | 2016-10-27 |
| Model Number | US906 |
| Catalog Number | US906 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN SURGICAL SA |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-27 |