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

Catalog Number 362780

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube there was foreign matter in the tube(s) biological and non-biological.This event occurred 60 times.The following information was provided by the initial reporter.The customer stated: there were some "flakes in the fluid of the empty tube.The tubes were unused.".

Manufacturer Narrative

Device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube there was foreign matter in the tube(s) biological and non-biological.This event occurred 60 times.The following information was provided by the initial reporter.The customer stated: there were some "flakes in the fluid of the empty tube.The tubes were unused.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-mar-02.H6: investigation summary bd received two (2) samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for foreign matter particles with the incident lot was observed.Additionally, sixty (60) retention samples from bd inventory were evaluated by visual examination and the issue of foreign matter particles were not observed.It is noted that lot # 0352839 expired on 2021/12/31 and the event date reported was (b)(6)2022.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 has been confirmed for the indicated failure mode of foreign matter particles based on the returned samples.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube there was foreign matter in the tube(s) biological and non-biological.This event occurred 60 times.The following information was provided by the initial reporter.The customer stated: there were some "flakes in the fluid of the empty tube.The tubes were unused.".

• 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: 13543207
• MDR Text Key: 285701243
• Report Number: 1917413-2022-00076
• 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,Followup
• Report Date: 03/10/2022

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: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 362780
• Device Lot Number: 0352839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• 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