MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS CF-250-3L manufactured by Charter Medical, Ltd..
[109625673]
The complaint sample, or pictures of the complaint device, was not returned to the manufacturer for investigation/review. The failure mode, or potential root cause for the reported incomplete seal is unknown.
Patient Sequence No: 1, Text Type: N, H10
[109625674]
The end user of the product reported an incomplete seal on the top right part of the bag, at the right side of the spike port. The issue was detected during product processing in a laboratory setting; there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00011 |
| MDR Report Key | 7542126 |
| Date Received | 2018-05-24 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2017-10-04 |
| Date Added to Maude | 2018-05-24 |
| 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 | 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS |
| Generic Name | 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS |
| Product Code | LPZ |
| Date Received | 2018-05-24 |
| Model Number | CF-250-3L |
| Catalog Number | CF-250-3L |
| Lot Number | 149035 |
| 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 | 2018-05-24 |