MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-20 for 10-20 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-50 manufactured by Charter Medical, Ltd..
[103281142]
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 from 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
[103281143]
While performing a final product fill in a cf-50 bag, the user reported a spill was coming from a hole in the freezing bag. The product was discarded; however the bag was saved for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00006 |
| MDR Report Key | 7355969 |
| Date Received | 2018-03-20 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2018-03-20 |
| 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 | 10-20 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Generic Name | 10-20 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2018-03-20 |
| Returned To Mfg | 2018-03-15 |
| Model Number | CF-50 |
| Catalog Number | CF-50 |
| Lot Number | 151497 |
| 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 | 2018-03-20 |