MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for 55 - 100 ML CRYOGENIC STORAGE CONTAINER CF-500 manufactured by Charter Medical, Ltd..
[145942138]
A single, used device was received for investigation. The returned bag was visually inspected; no issues were observed. The bag was inflated with compressed air and leak tested under water; a leak was detected in the film at the base of the center filler tube port. The leak was verified to be from a hole in the film, approximately 1/32-inch long. No other issues were observed on the returned bag. The user indicated their investigation determined the bag was damaged during handling after it was removed from cryogenic storage and being prepared for thawing. The ifu for this product states "port tubes and film are fragile in the frozen state and breakage may occur. Handle with care. "
Patient Sequence No: 1, Text Type: N, H10
[145942139]
The customer reported a bag breakage for a single cf-500 device. The customer indicated their internal investigation determined the bag was damaged during handling at their facility after it was removed from cryogenic storage and being prepared for thawing. The contents of the bag were administered to a patient. The user facility has a broken bag protocol, which requires collection of blood test cultures from the recipient along with prophylactic antibiotics. The blood culture tests were negative. There were no reports of patient injury or death as a result of this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2019-00003 |
| MDR Report Key | 8628777 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-04-11 |
| Device Manufacturer Date | 2018-07-22 |
| Date Added to Maude | 2019-05-21 |
| 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 | 55 - 100 ML CRYOGENIC STORAGE CONTAINER |
| Generic Name | 55 - 100 ML CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2019-05-21 |
| Returned To Mfg | 2019-04-26 |
| Model Number | CF-500 |
| Catalog Number | CF-500 |
| Lot Number | 153723 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-05-21 |