MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-22 for ROUND FILTERS W/INDICATOR US751 manufactured by Sps Medical Supply Corp.
[126228939]
Manufacturing site evaluation: investigation indicates the root cause of the reported issue is: chemical indicator ink has a viscosity which is too high for manufacturing equipment. High viscosity ink becomes stuck to applicators, resulting in splatter throughout the process. The current manufacturing process lacks specifications for ink viscosity. Immediate corrections have been put in place at the manufacturing site including manufacture. Increase in quality control sampling of filters to no less then every 30 minutes of manufacture along with enhanced training and visibility of this issue to operators trained in filter manufacture. Investigation of the makeup of the splatter is the same ink as the chemical indicator ink, due to the visible confirmation of ink color transition post-sterilization, and is not a contaminant nor a deficiency which affects the functionality of the product. This issue has been elevated to a capa to eliminate the issue.
Patient Sequence No: 1, Text Type: N, H10
[126228940]
It was reported by the healthcare professional to the company sales representative "the staff notice visible dark spots on filter aside from where the indicator dot is placed on the filter. " there was a 1 hour delay in surgery. No patient injury. No mention if additional intervention was needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00025 |
| MDR Report Key | 7991660 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-22 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-09-26 |
| Date Facility Aware | 2018-09-26 |
| Date Mfgr Received | 2018-09-26 |
| Date Added to Maude | 2018-10-22 |
| 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. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | 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 | KCT |
| Date Received | 2018-10-22 |
| Model Number | US751 |
| Catalog Number | US751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPS MEDICAL SUPPLY CORP |
| Manufacturer Address | 6789 W HENRIETTA ROAD RUSH NY 14543 US 14543 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-22 |