MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-13 for ROUND FILTERS W/INDICATOR US751 manufactured by Contract Manufacturer: Sps Medical Supply Corp.
[120137670]
(b)(4). Customer informed the manufacturer, that they could use us994 filters in place until they receive additional information on the status of the materials with the problem. The lot/batch/serial number of the device was unknown, therefore a batch history review cannot be performed. The device has not been returned for evaluation; therefore investigation results are not available. If new information becomes available, a supplemental report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[120137671]
It was reported that the customer is experiencing multiple brown spots on the filter and believe the sterilizer units are contaminated. No patient injury. There was delay in surgery. At the time of this report, the customer was cancelling elective cases. The or was down for 2 days. An unknown number of surgeries were rescheduled or cancelled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00017 |
| MDR Report Key | 7872641 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-13 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-08-14 |
| Date Facility Aware | 2018-12-06 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-09-13 |
| 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 | MRS 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 | DISPOSABLES CONTAINER SYSTEM |
| Product Code | KCT |
| Date Received | 2018-09-13 |
| Model Number | US751 |
| Catalog Number | US751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-09-13 |