MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-05 for CRYOMACS FREEZING BAG 50 ML 200-074-400 manufactured by Miltenyi Biotec Gmbh.
[23837914]
Na.
Patient Sequence No: 1, Text Type: N, H10
[23837915]
The customer reported that 5 out of 10 cryomacs freezing bags 50 ml exhibited cracking and breaching of integrity upon thawing. The cryomacs freezing bags were used in developmental upstream process, therefore, no patient treatment was affected. The event happened at: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2015-00008 |
| MDR Report Key | 5018602 |
| Date Received | 2015-08-05 |
| Date of Report | 2015-08-05 |
| Date of Event | 2015-07-10 |
| Date Mfgr Received | 2015-07-10 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2015-08-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 51429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRYOMACS FREEZING BAG 50 ML |
| Generic Name | CRYOMACS FREEZING BAG 50 ML |
| Product Code | KSR |
| Date Received | 2015-08-05 |
| Model Number | FREEZING BAG 50 ML |
| Catalog Number | 200-074-400 |
| Lot Number | 6130130002 |
| Device Expiration Date | 2016-02-29 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-08-05 |