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 2019-05-22 for ROUND FILTERS W/INDICATOR US751 manufactured by Sps Medical Supply Corp.
[145916646]
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
[145916647]
It was reported that there was an issue with the filter during surgery. During preparation for a total joint procedure, the color indicator of the sterility filter caused concern. This occurred on one of the instrument containers. The malfunction did not cause harm to the patient. It contributed to a delay of 30-45 minutes in which the set was re-sterilized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2019-00022 |
| MDR Report Key | 8633967 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-05-08 |
| Date Facility Aware | 2019-05-08 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-05-22 |
| 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 | 2019-05-22 |
| 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 | 2019-05-22 |