MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-09 for REDI-FLOW FINE FILTER SYSTEM 6/CS N/A 631040 manufactured by Biomet Biologics.
[59500303]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show the lot released with no recorded anomaly or deviation.
Patient Sequence No: 1, Text Type: N, H10
[59500304]
There was a hole in the filter system where the filter attaches to the plastic housing unit which caused a delay in the procedure of 1 to 2 hours.
Patient Sequence No: 1, Text Type: D, B5
[73000622]
This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch. No device was returned for evaluation. The device history records were reviewed for the filter with no deviations or anomalies being identified. Photos of the device were received and reviewed. It was found that there was damage to the device, so the complaint is considered to be confirmed; however, it is unknown where the damage occurred. The reported device is used for treatment. A definitive root cause of the reported issue cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-04572 |
| MDR Report Key | 6089200 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-09 |
| Date of Report | 2017-04-05 |
| Date of Event | 2016-10-10 |
| Date Mfgr Received | 2017-03-09 |
| Device Manufacturer Date | 2016-02-29 |
| Date Added to Maude | 2016-11-09 |
| 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. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDI-FLOW FINE FILTER SYSTEM 6/CS |
| Generic Name | TUBING, NONINVASIVE |
| Product Code | GAZ |
| Date Received | 2016-11-09 |
| Model Number | N/A |
| Catalog Number | 631040 |
| Lot Number | 216617 |
| ID Number | N/A |
| Device Expiration Date | 2018-10-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET BIOLOGICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-09 |