MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-27 for ROUND FILTERS W/INDICATOR US751 manufactured by Contract Manufacturer: Sps Medical Supply Corp.
[122008741]
Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[122008742]
It was reported that there are black spots on a disposable filter used in sterilization container system. No patient injury reported; however, a surgical delay was noted (length of delay is unknown at the time of this report).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00020 |
| MDR Report Key | 7916118 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-27 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-09-11 |
| Date Facility Aware | 2018-11-05 |
| Date Mfgr Received | 2018-11-05 |
| Date Added to Maude | 2018-09-27 |
| 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 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, NY 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROUND FILTERS W/INDICATOR |
| Generic Name | FILTER WITH INDICATOR |
| Product Code | JOJ |
| Date Received | 2018-09-27 |
| Model Number | US751 |
| Catalog Number | US751 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTRACT MANUFACTURER: SPS MEDICAL SUPPLY CORP |
| Manufacturer Address | 6789 W HENRIETTA ROAD RUSH NY 14543 US 14543 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-27 |