MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 400ML TRANSFER BAG WITH PIERCING PIN

Model Number T3104

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

A small fracture in the side of the middle port tube was verified.Investigation continuing.

Event Description

During processing of cell product, the user noticed a small pin hole leak at the middle port of the bag.The cell product inside the bag was transfused to the patient.

• Brand Name: 400ML TRANSFER BAG WITH PIERCING PIN
• Type of Device: 400ML TRANSFER BAG WITH PIERCING PIN
• Manufacturer (Section D): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103 6770
• Manufacturer (Section G): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103 6770
• Manufacturer Contact: lisa hinshaw ; 3948-a westpoint blvd.; winston salem, NC 27103-6770 ; 3367686447
• MDR Report Key: 9635090
• MDR Text Key: 191398709
• Report Number: 1066733-2020-00005
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/13/2023
• Device Model Number: T3104
• Device Catalogue Number: T3104
• Device Lot Number: 157358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR