MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 368861

Device Problem Missing Information (4053)

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

Event Date 11/24/2022

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.

Event Description

It was reported when using the bd vacutainer® k2e 7.2mg plus blood collection tube there was no label or missing label information.The following information was provided by the initial reporter.The customer stated: "there are tubes where the label is not stuck properly.Some tubes have no label, often the tube next to them has 2.The adhesive edges are sometimes loose which can cause interference on the pre-analytical module.".

Event Description

It was reported when using the bd vacutainer® k2e 7.2mg plus blood collection tube there was no label or missing label information.The following information was provided by the initial reporter.The customer stated: "there are tubes where the label is not stuck properly.Some tubes have no label, often the tube next to them has 2.The adhesive edges are sometimes loose which can cause interference on the pre-analytical module.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-01-03.H.6.Investigation summary: bd received one photograph and 6 samples from the customer in support of this complaint.An evaluation of the samples and photo attached shows evidence of lifted labels and missing labels on the tubes.Additionally, 100 retained samples from the bd inventory were visually checked and no defects were found.Bd was able to duplicate or confirm the customer¿s indicated failure from the photograph and samples provided, however, retained samples were satisfactory.Bd was not able to identify a root cause for the 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.

• Brand Name: BD VACUTAINER® K2E 7.2MG PLUS 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
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16030201
• MDR Text Key: 308369815
• Report Number: 9617032-2022-01310
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: BK050036
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 368861
• Device Catalogue Number: 368861
• Device Lot Number: 2283254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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