MAUDE Adverse Event Report: TERUMO BCT, INC. COBE 2991 CELL PROCESSING SET; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

Catalog Number 90819

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/09/2018

Event Type  malfunction  

Event Description

During the washing procedure of a bone marrow product on the cobe 2991, a small tear formed at the exit port of the bag.

• Brand Name: COBE 2991 CELL PROCESSING SET
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 west collins ave; lakewood CO 80215
• MDR Report Key: 7572940
• MDR Text Key: 110224395
• Report Number: 7572940
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 90819
• Device Lot Number: 08A15001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2018
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1