MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-19 for CRYOMACS FREEZING BAGS 250 N/A 200-074-401 manufactured by Miltenyi Biotec Gmbh.
[73266461]
Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[73266462]
The customer complained on cracked cryomacs? Freezing bag(s) 250 which were either removed from the liquid nitrogen freezer at their facility in (b)(4) u. S. , or transported to customers in the (b)(6) via plane using a cryo-containment unit (< -160 c). The vrhole freezing/thawing process as well as the amount of cracked bags for each lot described by the customer is actually rather unclear. Also the transport conditions for long-distance transport to (b)(6) customers is not comprehensively described by pct. Up to now there is also no information provided by the customer on the clinical outcome for the patients involved. The date of event is also unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2017-00012 |
| MDR Report Key | 6504802 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-04-19 |
| Date of Report | 2017-04-18 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2015-05-07 |
| Date Added to Maude | 2017-04-19 |
| 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 | MS NANCY JOHANSEN |
| Manufacturer Street | 120 BEACON ST SUITE 200 |
| Manufacturer City | SOMERVILLE MA 02143 |
| Manufacturer Country | US |
| Manufacturer Postal | 02143 |
| 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 | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOMACS FREEZING BAGS 250 |
| Generic Name | CRYOMACS FREEZING BAGS 250 |
| Product Code | LPZ |
| Date Received | 2017-04-19 |
| Model Number | N/A |
| Catalog Number | 200-074-401 |
| Lot Number | 6150213015 |
| Device Expiration Date | 2018-01-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-04-19 |