MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 365057

Device Problem Obstruction of Flow (2423)

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

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

A 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 while using bd vacutainer® barricor¿ lh plasma blood collection tube there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: problem with aspiration by cobas 6000 for a long period of time additionally, on 2021-04-21 the bd sales consultant provided the following additional information: the side effects are like needle blockage and delayed results to my knowledge.

Event Description

It was reported while using bd vacutainer® barricor¿ lh plasma blood collection tube there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: problem with aspiration by cobas 6000 for a long period of time additionally, on 2021-04-21 the bd sales consultant provided the following additional information: the side effects are like needle blockage and delayed results to my knowledge.

Manufacturer Narrative

H6: investigation summary bd did not receive samples or photographs from the customer in support of this complaint.Therefore, 10 retained samples were drawn with water.All filled as expected.Bd was unable to duplicate or confirm the customer¿s indicated failure mode.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.See h10.

• Brand Name: BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 11766424
• MDR Text Key: 249973286
• Report Number: 9617032-2021-00403
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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: 03/31/2022
• Device Catalogue Number: 365057
• Device Lot Number: 0311964
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1