MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS CF-250-3L manufactured by Charter Medical, Ltd..
[129073676]
A single, used sample was received for investigation. The bag was charged with compressed air and leak tested under water; a leak was discovered from the right top corner of the bag. The area where the observed leak originated was examined, using a magnification inspection lamp, and a hole was verified in the film. The examination also revealed a film off-set issue in the perimeter weld at the port section of the bag. The offset is indicative of a film mis-alignment issue, which would have occurred during the manufacturing process. During the manufacturing process, the bag is placed into tooling for a welding process, which requires manual film alignment. As a result of the film misalignment observed on the returned sample, the manufacturing tooling likely placed stress on the film at the hole location and produced a tear, or weak area, in the film.
Patient Sequence No: 1, Text Type: N, H10
[129073677]
The user of the device discovered blood product leaking at the edge of the bag. There was no report of an adverse event or need for additional medical intervention as a result of this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00022 |
| MDR Report Key | 8110122 |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2018-10-26 |
| Device Manufacturer Date | 2018-04-03 |
| Date Added to Maude | 2018-11-28 |
| 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 | 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS |
| Generic Name | 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS |
| Product Code | LPZ |
| Date Received | 2018-11-28 |
| Model Number | CF-250-3L |
| Catalog Number | CF-250-3L |
| Lot Number | 150349 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHARTER MEDICAL, LTD. |
| Manufacturer Address | 3948-A WESTPOINT BLVD. WINSTON SALEM 27103 US 27103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-28 |