MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-02 for MINI GPS 6 PACK N/A 800-1007A manufactured by Biomet Orthopedics.
[4921035]
It was reported that patient underwent a procedure utilizing a platelet separation kit for the extraction of platelet rich plasma (prp) on (b)(6) 2014. During the procedure, the kit did not separate the prp properly and became contaminated with what looked like red blood cells (rbcs). The kit appeared to have a break in the seal between the chambers. A different kit was used to complete the procedure; however, a delay of at least 30 minutes occurred while the other kit was set up.
Patient Sequence No: 1, Text Type: D, B5
[12244106]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of the inspection records and certificate of conformance, indicates that lot was received with no recorded anomaly or deviation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-07902 |
| MDR Report Key | 4133900 |
| Report Source | 07 |
| Date Received | 2014-10-02 |
| Date of Report | 2014-09-04 |
| Date of Event | 2014-08-21 |
| Date Mfgr Received | 2014-09-04 |
| Device Manufacturer Date | 2014-01-28 |
| Date Added to Maude | 2014-10-02 |
| 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 | 0 |
| Event Location | 0 |
| 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 | MINI GPS 6 PACK |
| Generic Name | BLOOD BANK SUPPLIES |
| Product Code | KSS |
| Date Received | 2014-10-02 |
| Model Number | N/A |
| Catalog Number | 800-1007A |
| Lot Number | 400389 |
| ID Number | N/A |
| Device Expiration Date | 2019-01-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-10-02 |