MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-31 for CRYOMACS FREEZING BAGS 250 N/A 200-074-401 manufactured by Miltenyi Biotec B.v. & Co. Kg.
[177268570]
Breaks were observed upon thawing on the side of the bag. Breakage occured during infusion. The physician agreed to continue the infusion. A sterility test was performed and came out negative. The customer did not use an overwrap bag to stabilize the bag and enable rescue of the frozen material. More relevant in this case is that probably a scissor clamp was used to hold the bag, what caused the edges oto break. This is the second complaint for this lot with a incident rate of 0. 01%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2020-00005 |
| MDR Report Key | 9653700 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-01-31 |
| 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 | DR. BETTINA-JUDITH H |
| Manufacturer Street | FRIEDRICH-EBERT-STR. 68 |
| Manufacturer City | BERGISCH GLADBACH, 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal | 51429 |
| Manufacturer G1 | MILTENYI BIOTEC B.V. & CO. KG |
| Manufacturer Street | FRIEDRICH-EBERT-STR. 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 | 3 |
| Brand Name | CRYOMACS FREEZING BAGS 250 |
| Generic Name | CRYOMACS FREEZING BAGS 250 |
| Product Code | KSR |
| Date Received | 2020-01-31 |
| Model Number | N/A |
| Catalog Number | 200-074-401 |
| Lot Number | 6190110027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC B.V. & CO. KG |
| Manufacturer Address | FRIEDRICH-EBERT-STR. 68 BERGISCH GLADBACH, 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |