MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-16 for CRYOMACS FREEZING BAGS 50 N/A 200-074-400 manufactured by Miltenyi Biotec Gmbh.
[146090813]
The reason for the breakage was a clear application failure by the customer. The bags were filled with a higher volume than clearly indicated in the product information sheet. An overfilling results in mechanical stress to the bag that can easily lead to a breakage. This was the first complaint with this failure description for this lot. This one complaint refers to 4 bags. Complaint rate (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146090814]
The customer complains four cracked freezing bags 50 of lot 6170829012. The freezing bags were cracked at the fold line from bag and label area. The loaded volume was over 30 ml while the product information sheet states a recommended filling volume of 10-20 ml. No overwrap bag was used. Due to the loss of material a second treatment, that might be necessary under certain circumstances, would not be possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2019-00002 |
| MDR Report Key | 8518652 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-03-25 |
| Date Facility Aware | 2019-03-26 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-04-16 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOMACS FREEZING BAGS 50 |
| Generic Name | CRYOMACS FREEZING BAGS 50 |
| Product Code | KSR |
| Date Received | 2019-04-16 |
| Model Number | N/A |
| Catalog Number | 200-074-400 |
| Lot Number | 6170829012 |
| 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-STR. 68 BERGISCH GLADBACH, 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-16 |