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 2018-12-01 for ROUND FILTERS W/INDICATOR US751 manufactured by Contract Manufacturer: Sps Medical Supply Corp.
[129095997]
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
[129095998]
It was reported that while preparing for surgery, the instrument container was opened and it was noted that the chemical filter in the bottom of the case had not completely changed color. The issue caused a brief delay of 10 minutes during preparation for a total hip operation. The filter usually changes color and is one of the indicators of sterility used during instrument processing. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00043 |
| MDR Report Key | 8122251 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-01 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-06 |
| Date Facility Aware | 2018-12-05 |
| Date Mfgr Received | 2018-12-05 |
| Date Added to Maude | 2018-12-01 |
| 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 | 2018-12-01 |
| Returned To Mfg | 2018-11-13 |
| Model Number | US751 |
| Catalog Number | US751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-12-01 |