MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for 30 -70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250 manufactured by Charter Medical, Ltd..
[127866517]
The cf-250 device has two spike port components. The spike port component contains a septum membrane in the interior tube. The cf-250 is 100% leak tested during production. The returned bag was visually inspected; both spike port components of the bag contained spike components. The returned bag had an area of interest identified on one of the spike port components of the bag. Two observations were noted: a tear/hole was verified on one of the spike ports. The hole occurred in the side of the spike port tube, below the septum. A hole at this location would have been detected upon filling if it existed at that time (i. E. Before a spike would have been inserted into the spike port). The hole was reported after the bag had been frozen and thawed. Additionally, a hole in this location would likely be detected during production leak test if it existed at that time. The remnants of the spike port septum membrane were observed inside the bag. This observation is likely an indication of excessive force or incorrect user technique during the spiking process. The location and nature of the hole in the spike port component, along with the process step (after thawing and hanging the bag) when the leak was detected, suggests user excessive force or spiking technique likely contributed to the hole on the returned sample.
Patient Sequence No: 1, Text Type: N, H10
[127866518]
A leak, from the port component of a single cf-250 product was reported by the user facility. The bag was thawed for infusion and hung. A hole was observed in the port component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00018 |
| MDR Report Key | 8040144 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-10-04 |
| Device Manufacturer Date | 2016-08-12 |
| Date Added to Maude | 2018-11-05 |
| 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 | 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 | 0 |
| Brand Name | 30 -70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Generic Name | 30 -70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2018-11-05 |
| Returned To Mfg | 2018-10-12 |
| Model Number | CF-250 |
| Catalog Number | CF-250 |
| Lot Number | 145979 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-11-05 |