MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-01-18 for GPS III SINGLE KIT W/30ML ACDA N/A 800-1003A manufactured by Biomet Biologics.
[2427589]
It was reported that during a procedure on (b)(6) 2011, patient's blood was placed in a platelet concentration kit. As the blood was put into the cylinder, the blood started to be expelled out the top of the cylinder. Upon inspection of the cylinder, it was noted that there was a hole on the top of the cylinder where a filter is usually located.
Patient Sequence No: 1, Text Type: D, B5
[9535283]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of receiving certificate of conformance showed that lot released with no recorded anomaly or deviation. Review of device sales history shows eight devices confirmed used with no reported complications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00061 |
| MDR Report Key | 2420597 |
| Report Source | 07 |
| Date Received | 2012-01-18 |
| Date of Report | 2011-12-19 |
| Date of Event | 2011-12-19 |
| Date Mfgr Received | 2011-12-19 |
| Device Manufacturer Date | 2011-10-07 |
| Date Added to Maude | 2012-08-07 |
| 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. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET BIOLOGICS |
| 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 | GPS III SINGLE KIT W/30ML ACDA |
| Generic Name | SUPPLIES, BLOOD BANK |
| Product Code | KSS |
| Date Received | 2012-01-18 |
| Model Number | N/A |
| Catalog Number | 800-1003A |
| Lot Number | 112953 |
| ID Number | N/A |
| Device Expiration Date | 2014-09-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2012-01-18 |