MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-27 for CRYOMACS FREEZING BAG 500 N/A 200-074-402 manufactured by Miltenyi Biotec Gmbh.
[44508143]
Patient Sequence No: 1, Text Type: N, H10
[44508144]
The customer reported on cracked luer connector threads within three cryomacs freezing bags 500 during fluid transfer prior to freezing. Since the customer could rescue the cellular material any risk for the patient could be ruled out. The date of the event is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00063 |
| MDR Report Key | 5612767 |
| Date Received | 2016-04-27 |
| Date of Report | 2016-04-27 |
| Device Manufacturer Date | 2015-11-10 |
| Date Added to Maude | 2016-04-27 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRYOMACS FREEZING BAG 500 |
| Generic Name | FREEZING BAG |
| Product Code | KSR |
| Date Received | 2016-04-27 |
| Returned To Mfg | 2016-04-05 |
| Model Number | N/A |
| 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 | 2016-04-27 |