MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS CF-250-3L manufactured by Charter Medical, Ltd..
[120576334]
A single, used bag was received and visually inspected by engineering staff. Inspection revealed a film tear under the right spike port. The tear was jagged and non-linear, approximately 3/4-inch long, and extended from below the tear cap port to the perimeter weld location. A small portion of the tear extended approximately 1/8-inch into the perimeter weld. A capa had previously been issued to investigate film breaks of this nature. A review of the capa investigation indicated failure modes of this type have been reproduced by introducing an air bubble inside the bag prior to freezing. An air bubble could rapidly expand during the thawing process, resulting in a film tear. The evidence observed from the returned sample indicates the likely root cause of the cracked film was the existence of an air bubble in the bag prior to freezing. Precautions for air bubbles inside the bag prior to freezing are addressed in the product ifu's.
Patient Sequence No: 1, Text Type: N, H10
[120576335]
The bag was used to store and transport a manufactured product. The end user experienced a leak from a possible film tear in a cf-250-3l device while the bag was being thawed after frozen for 3-months. The bag contained a finished manufactured product used for a patient study point. The contents of the bag were not infused into a patient. There were no adverse events or additional medical intervention required as a result of this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00014 |
| MDR Report Key | 7876191 |
| Date Received | 2018-09-14 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-08-14 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2017-12-07 |
| Date Added to Maude | 2018-09-14 |
| 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. JESSICA HUGHES |
| 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 | 2018-09-14 |
| Returned To Mfg | 2018-08-21 |
| Model Number | CF-250-3L |
| Catalog Number | CF-250-3L |
| Lot Number | 149037 |
| Device Availability | R |
| 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 NC 27103 US 27103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-14 |