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 2019-05-07 for ROUND FILTERS W/INDICATOR US751 manufactured by Sps Medical Supply Corp.
[144966951]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report. Investigation on-going.
Patient Sequence No: 1, Text Type: N, H10
[144966952]
It was reported that there was an issue with the round filters. While opening instrument sets prior to surgery, brown spots were found on the filters, which are sterility indicators. The patient was not yet in the operating room or under anesthesia; however, a delay of 5-10 minutes occurred while another tray was opened instead. Additional information was not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2019-00011 |
| MDR Report Key | 8588743 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-03-05 |
| Date Facility Aware | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-05-07 |
| 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. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | SPS MEDICAL SUPPLY CORP |
| Manufacturer Street | 6789 W HENRIETTA RD |
| 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 | FRG |
| Date Received | 2019-05-07 |
| Model Number | US751 |
| Catalog Number | US751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPS MEDICAL SUPPLY CORP |
| Manufacturer Address | 6789 W HENRIETTA RD RUSH NY 14543 US 14543 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-07 |