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 2018-02-21 for ROUND FILTERS W/INDICATOR US751 manufactured by Sps Medical Supply Corp.
[100783775]
(b)(4). Manufacturing site evaluation: evaluation on-going device not returned.
Patient Sequence No: 1, Text Type: N, H10
[100783776]
Country of complaint: usa hospital employee did not check filters before taking the container into the steril field during the setup process. Patient had been given a paralytic before surgery. Before the patient had been opened, it was noticed in the or that the filters contained holes going all the way through the filters which matched the pattern of the holes in the container. They did not have another set available, so they had to cancel surgery all med watch submissions related to this report are: 2916714-2018-00004, 2916714-2018-00005.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00005 |
| MDR Report Key | 7287218 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-21 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-01-23 |
| Date Facility Aware | 2018-01-29 |
| Date Mfgr Received | 2018-01-25 |
| Date Added to Maude | 2018-02-21 |
| 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 |
| 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 G1 | SPS MEDICAL SUPPLY CORP |
| Manufacturer Street | 6789 W HENRIETTA RD MONROE |
| 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 | 2018-02-21 |
| Model Number | US751 |
| Catalog Number | US751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 MONROE RUSH NY 14543 US 14543 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-21 |