MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-750 manufactured by Charter Medical, Ltd..
[112455798]
A single, used bag was received for investigation. The bag was visually examined and no issues were observed. The bag was leak tested and a film pinhole was verified near the perimeter seal at the top portion of the bag. Visual examination of the bag under a magnification inspection lamp verified a small hole in the bag film. No other issues were observed on the bag. There is no information to suggest the hole existed at the time the bag was produced at the manufacturing facility. Other than the hole itself, there was no evidence of excessive force or damage to the bag, or associated ports and tubing. It is unknown if a manufacturing issue, or user facility issue, may have contributed to the pinhole, however there was no direct evidence of a root cause.
Patient Sequence No: 1, Text Type: N, H10
[112455799]
The cf-750 was removed from its packaging pouch and filled with 100ml of a cell product. As the bag was being packed into a cassette, a leak was detected. There was no patient contact or infusion of cell product from the bag associated with this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00013 |
| MDR Report Key | 7637288 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2018-05-30 |
| Device Manufacturer Date | 2018-01-15 |
| Date Added to Maude | 2018-06-26 |
| 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 | 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Generic Name | 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2018-06-26 |
| Returned To Mfg | 2018-06-08 |
| Model Number | CF-750 |
| Catalog Number | CF-750 |
| Lot Number | 151751 |
| 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 | 2018-06-26 |