MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-18 for CRYOMACS FREEZING BAG 500 ML 200-074-402 manufactured by Miltenyi Biotec Gmbh.
[40662123]
The contract manufacturer of the t connections was informed to provide a statement on the origin and analysis of the green-colored inclusion. As soon as this information becomes available by (b)(4), will share with agency.
Patient Sequence No: 1, Text Type: N, H10
[40662124]
The cryomacs freezing bag 500 ml comprises inclusions and discolorations on the t-connections. No patient was affected because the malfunction was detected prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00055 |
| MDR Report Key | 5510287 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-18 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-02-19 |
| Date Mfgr Received | 2016-02-19 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2016-03-18 |
| 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 NANCY JOHANSEN |
| Manufacturer Street | 85 HAMILTON ST |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6172180062 |
| Manufacturer G1 | MILTENYI BIOTEC GMBH |
| Manufacturer Street | FRIEDRICH-EBERT-STRASSE 68 |
| Manufacturer City | BERGISCH GLADBACH, 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 51429 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOMACS FREEZING BAG |
| Generic Name | CRYOMACS FREEZING BAG |
| Product Code | OVG |
| Date Received | 2016-03-18 |
| Returned To Mfg | 2016-03-02 |
| Model Number | 500 ML |
| Catalog Number | 200-074-402 |
| Lot Number | 6150914017 |
| Device Expiration Date | 2018-08-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC GMBH |
| Manufacturer Address | FRIEDRICH-EBERT-STRASSE 68 BERGISCH GLADBACH, 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-18 |