MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD TUBE K2EDTA PLH 13X75 2.0 SLBL LAV JLP; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367846

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

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

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples and no photos were returned by the customer in support of this complaint.Therefore, (b)(4) retention samples from the bd inventory were visually inspected with no issues being identified.Bd was unable to confirm the customer¿s indicated failure mode based on the investigation completed.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 tube k2edta plh 13x75 2.0 slbl lav jlp there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "there was an foreign matter in the tube.".

• Brand Name: BD TUBE K2EDTA PLH 13X75 2.0 SLBL LAV JLP
• 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: 16026817
• MDR Text Key: 306841341
• Report Number: 1917413-2022-00801
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 12/08/2022

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: 06/30/2023
• Device Catalogue Number: 367846
• Device Lot Number: 2080646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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