MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 360057

Device Problem Material Deformation (2976)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

E.5.Initial reporter phone #: (b)(6).There were multiple medical device types reported to be involved.The information for the additional device type is as follows: g.2.Medical device type: gim.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g5.Pma / 510(k)#: k213670.H.3.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 before using bd tube k2edta plh 13x75 4.0 plbl lav br the cap had molding defects.There was no report of impact to the patient or user.

Event Description

It was reported before using bd tube k2edta plh 13x75 4.0 plbl lav br the cap had molding defects.There was no report of impact to the patient or user.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but one photo was returned in support of this complaint.Photo was examined and indicated the reported failure mode of defective product.Bd was able to confirm the reported incident through the provided photo.Additionally, 200 retention samples were visually evaluated.The defect could not be confirmed through retention samples.Device history records have been reviewed, there have been no related quality notifications, and all processes and final inspections are in compliance with specification requirements.Bd was able to confirm the report defect based on the provided photo.Bd was unable to determine the root cause of the reported issue.Complaints received for this device and the condition reported will continue to be tracked and evaluated.The information will be captured in trend reports and monitored.Our business team regularly analyzes collected data to identify emerging trends.

• Brand Name: BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19075135
• MDR Text Key: 340111588
• Report Number: 3003916417-2024-00089
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903678618
• UDI-Public: (01)30382903678618
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 360057
• Device Lot Number: 3177867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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