MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-13 for 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250 manufactured by Charter Medical, Ltd..
[120576291]
The returned bag was visually inspected; a tear in the film, approximately 1/8-inch in length, was observed in the junction area of two bag welds. The film edges of the tear had a stretch appearance as if the film had been pulled apart. The failure mode was unique from previous leak reports involving this product style in several ways: previous complaints have been attributed to user handling technique issues after the bags were frozen. This one occurred during the filling process. Failure modes from previous reports presented themselves as small pin holes or film cracks. The exact root cause was undetermined. However, a review of the bag production process indicated a single manual process step where an issue of this nature could possibly occur. The bag is produced with 2 separate layers of film, which are manually placed on tooling and welded. If one of the film layers is not manually placed in a flat orientation, there is a possibility the weld tooling could pinch the film near the port weld junction and result in a tear or hole. This is the location where the bag tear was observed on the returned sample. Since there have been no known previous reports of this nature this issue appears to be an isolated occurrence.
Patient Sequence No: 1, Text Type: N, H10
[120576292]
The end user experienced a leak from a possible film tear in a cf-250 device while the bag was being filled. The cell material was not salvaged from the bag and was not infused into the 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 | 1066733-2018-00015 |
| MDR Report Key | 7872603 |
| Date Received | 2018-09-13 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-13 |
| Device Manufacturer Date | 2017-11-08 |
| Date Added to Maude | 2018-09-13 |
| 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 | MS. JESSICA HUGHES |
| Manufacturer Street | 3948-A WESTPOINT BLVD. |
| Manufacturer City | WINSTON SALEM 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 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 |
| Generic Name | 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2018-09-13 |
| Returned To Mfg | 2018-08-21 |
| Model Number | CF-250 |
| Catalog Number | CF-250 |
| Lot Number | 151223 |
| 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 | 2018-09-13 |