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 2018-12-17 for ROUND FILTERS W/INDICATOR US751 manufactured by Contract Manufacturer: Sps Medical Supply Corp.
[130622266]
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
[130622267]
It was reported that the indicators on filters were not changing color. The indicators on filters used for instrument containers were not functioning as intended. It was felt that they were not discoloring as they should. There was no patient involvement or harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00045 |
| MDR Report Key | 8171654 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-17 |
| Date of Report | 2019-01-30 |
| Date of Event | 2018-11-29 |
| Date Facility Aware | 2019-01-25 |
| Date Mfgr Received | 2019-01-25 |
| Date Added to Maude | 2018-12-17 |
| 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 | CONTRACT MANUFACTURER: SPS MEDICAL SUPPLY CORP |
| Manufacturer Street | 6789 W HENRIETTA ROAD |
| Manufacturer City | RUSH NY 14543 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14543 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROUND FILTERS W/INDICATOR |
| Generic Name | STERILE TECHNOLOGY |
| Product Code | JOJ |
| Date Received | 2018-12-17 |
| Model Number | US751 |
| Catalog Number | US751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-17 |