MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 80-190 ML FILL VOLUME CRYOGENIC STORAGE CONTAINER

Model Number CF-750

Device Problems Break (1069); Crack (1135); Fracture (1260); Device Issue (2379); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

Four unused bags and three used bags were returned for investigation.No issues were observed on the unused bags.The bags were not used in a clinical setting.Irregular film fractures were observed on each of the three used bags.The film fractures were located on one side of all three returned used bags.The location and nature of the fractures suggested air bubbles may have been introduced into the bag when filling with fluid.The user provided pictures of cf-750 bags with fluid prior to freezing.Large bubbles were observed inside the bags.The bubbles inside the bags would correspond to the approximate area where the bag fractures were located on the three returned bags.There are other causes that could potentially result in bag fractures: - overfilling the bag.An overfilled bag could create resistance during insertion and removal of the bag from the metal cassette.- moisture on the exterior surface of the bag or cassette interior when the bag is inserted into the metal cassette.Moisture may cause the bag film to freeze to the interior cassette surface, thus potentially resulting in damage when the frozen bag is removed from the cassette.- an unknown material anomaly.The product instruction for use sheet is provided with each cf-750 device.Review of the ifu version provided with lot 149522 has the following precautions: - "port tubes and film are fragile in the frozen state and breakage may occur.Handle with care." - "do not overfill." - "remove as much air as possible from the container." - "ensure bag exterior and protective freezing cassettes are dry prior to initiating freezing protocol.Moisture on exterior of bag or on cassette could cause adherence of bag to cassette resulting in difficulty of bag removal.".

Event Description

The bags were placed in ln2 on (b)(6).The cracks were discovered when the bags were removed from the ln2 tank prior to thawing on (b)(6).There was no contact with a patient following discovery of the bag breaks.There was no injury, death or further medical intervention required as a result of this occurrence.There was no medical staff exposure as a result of this occurrence.

• Brand Name: 80-190 ML FILL VOLUME CRYOGENIC STORAGE CONTAINER
• Type of Device: 80-190 ML FILL VOLUME CRYOGENIC STORAGE CONTAINER
• Manufacturer (Section D): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103
• Manufacturer (Section G): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103
• Manufacturer Contact: jessica hughes ; 3948-a westpoint blvd.; winston salem, NC 27103 ; 3367686447
• MDR Report Key: 6791907
• MDR Text Key: 82937277
• Report Number: 1066733-2017-00008
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2021
• Device Model Number: CF-750
• Device Catalogue Number: CF-750
• Device Lot Number: 149522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1