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

Catalog Number 365056

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported when using the bd vacutainer¿ barricor" lh plasma blood collection tube there was tube extenders with molding defects that can be used.The following information was provided by the initial reporter: translated to english.The customer stated: "it looks like the tube has been "melted" on the bottom.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/11/2021.H.6.Investigation: bd received 35 collapsed samples from the customer in support for this complaint.100 retained samples were visually inspected, and no collapsed samples were found.Bd was able to confirm the customers indicated failure mode with the samples provided.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.

Event Description

It was reported when using the bd vacutainer® barricor¿ lh plasma blood collection tube there was tube extenders with molding defects that can be used.The following information was provided by the initial reporter: translated to english.The customer stated: "it looks like the tube has been "melted" on the bottom.".

• Brand Name: BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES
• 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: 11369658
• MDR Text Key: 233945709
• Report Number: 9617032-2021-00163
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 365056
• Device Lot Number: 0245305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1