MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250 manufactured by Charter Medical, Ltd..
[122305425]
The complaint sample, or pictures of the complaint device, was not returned to the manufacturer for investigation/review. The failure mode, or potential root cause for the reported leak is unknonwn.
Patient Sequence No: 1, Text Type: N, H10
[122305426]
A leak, near the port of a single cf-250 product, was reported by the user. This occurrence happened (b)(6) 2018, however the user facility stated this event was not properly filed by a previous employee at the user's facility and charter medical was not notified at the time of the event. There was no additional medical intervention required as a result of this occurrence. The blood product in the bag was discarded and was not infused into a patient. The bag is no longer available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00016 |
| MDR Report Key | 7918648 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-08-30 |
| Device Manufacturer Date | 2017-09-12 |
| Date Added to Maude | 2018-09-28 |
| 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 | MR. TODD MEINECKE |
| Manufacturer Street | 3948-A WESTPOINT BLVD. |
| Manufacturer City | WINSTON SALEM NC 27103 |
| Manufacturer Country | US |
| Manufacturer Postal | 27103 |
| Manufacturer Phone | 3367686447 |
| Manufacturer G1 | CHARTER MEDICAL, LTD. |
| Manufacturer Street | 3948-A WESTPOINT BLVD. |
| Manufacturer City | WINSTON SALEM NC 27103 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27103 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Generic Name | 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2018-09-28 |
| Model Number | CF-250 |
| Catalog Number | CF-250 |
| Lot Number | 150645 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHARTER MEDICAL, LTD. |
| Manufacturer Address | 3948-A WESTPOINT BLVD. WINSTON SALEM NC 27103 US 27103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-28 |