MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-28 for SINGLE USE PAPER FILTER WITH INDICATOR JK095 manufactured by Aesculap Ag.
[78694060]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[78694061]
(b)(6). It was reported that particles was found inside the containers that have been sterilized as long as two to six months ago. The particles in the containers are darker in color and the particles are solid. The lids also had some dust on them in the crevices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2017-00345 |
| MDR Report Key | 6673985 |
| Date Received | 2017-06-28 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-06-02 |
| Date Facility Aware | 2017-06-26 |
| Date Mfgr Received | 2017-06-07 |
| Date Added to Maude | 2017-06-28 |
| 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 Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SINGLE USE PAPER FILTER WITH INDICATOR |
| Generic Name | DISPOSABLES CONTAINER SYSTEM |
| Product Code | OWP |
| Date Received | 2017-06-28 |
| Model Number | JK095 |
| Catalog Number | JK095 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-28 |