MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362780

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube, the device experienced underfill or low draw of a tube with blood.This event occurred 60 times.The following information was provided by the initial reporter.The customer stated: the customer complains that only 2-3 ml of blood is drawn into the tube.The blood sample was checked, it is not because of it, but clearly on the tube.In the past 2-3 weeks, 5-6 tubes were affected.The customer complains that the tubes draw only 2-3ml blood.They checked the blood collection, everything was done correctly, the problems are the tubes.During the last 2-3 weeks the problem occurred 5-6 times resp.5-6 tubes were concerned.

Manufacturer Narrative

Investigation summary: bd had not received samples or photos for investigation.Therefore, ten (10) retention samples from bd inventory were evaluated by functional draw testing and no issues were observed relating to underfill as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality notifications.This complaint is unable to be confirmed for the indicated failure mode of underfill based on retention sample testing.Bd was not able to identify a root cause for the indicated failure mode.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13022829
• MDR Text Key: 285013583
• Report Number: 1917413-2021-01062
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K891407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 362780
• Device Lot Number: 0311204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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