MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-16 for 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS CF-250-3L manufactured by Charter Medical, Ltd..
[127866609]
The sample was not returned for investigation, however the user provided pictures of a bag from lot 149037. The pictures indicated a bag with irregular film cracks over the top portion of the bag and into the port area. No other issues were observed from the bag pictures. 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 provided pictures suggests 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
[127866610]
The information provided by the customer indicated a bag cracked during the thawing process. The crack occurred in a laboratory setting and did not involve a patient. 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 | 1066733-2018-00021 |
| MDR Report Key | 8077389 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2017-12-07 |
| Date Added to Maude | 2018-11-16 |
| 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 |
| 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 | 3 |
| 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 | 2018-11-16 |
| Model Number | CF-250-3L |
| Catalog Number | CF-250-3L |
| Lot Number | 149037 |
| 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 | 2018-11-16 |