MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-03 for BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM JF949 manufactured by Aesculap Ag.
[113168940]
(b)(4). Manufacturing site evaluation: evaluation on-going
Patient Sequence No: 1, Text Type: N, H10
[113168941]
Country of complaint: usa there is an increasing amount of sets being sent back to spd due to residue found inside container after sterilization. The or staff is doing a "white glove test" - where they will swipe the bottom of the container after removing the basket. After swiping the bottom of the container the or staff (in some cases) are finding a dark residue on glove. No patient injury. Delay in surgery all medwatch submissions related to this report are: 9610612-2018-00288, 9610612-2018-00289, 9610612-2018-00290, 9610612-2018-00291, 9610612-2018-00292, 9610612-2018-00296, 9610612-2018-00312.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00312 |
| MDR Report Key | 7660578 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-03 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-06-01 |
| Date Facility Aware | 2018-06-22 |
| Date Mfgr Received | 2018-06-04 |
| Date Added to Maude | 2018-07-03 |
| 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 | 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 | 3 |
| Brand Name | BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM |
| Generic Name | CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN |
| Product Code | FRG |
| Date Received | 2018-07-03 |
| Model Number | JF949 |
| Catalog Number | JF949 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-07-03 |