MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® EDTA 2K; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367846

Device Problems Difficult to Insert (1316); Short Fill (1575)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® edta 2k, the device experienced underfill or low draw of a tube with blood and whole tube push off.This event occurred once.The following information was provided by the initial reporter.The customer stated: this is a report about a draw volume issue.According to the customer's report, the tube drew only 1ml or less, with the flow rate being quite slow.The hcp felt the pressure that pushed it back.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated with additional information: d9: device available for evaluation: yes; d9: returned to manufacturer on: 2022-11-15.H.3.Investigation summary: bd received 50 samples from the customer in support of this complaint.20 customer samples along with 10 retention samples from the bd inventory were functionally tested and the issues of underfill and tube push off were not observed.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the customer samples and the retention samples did not exhibit the customer¿s failure modes of ¿underfill and tube push off¿.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.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® edta 2k, the device experienced underfill or low draw of a tube with blood and whole tube push off.This event occurred once.The following information was provided by the initial reporter.The customer stated: this is a report about a draw volume issue.According to the customer's report, the tube drew only 1ml or less, with the flow rate being quite slow.The hcp felt the pressure that pushed it back.

• Brand Name: BD VACUTAINER® EDTA 2K
• 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: 15746788
• MDR Text Key: 305254338
• Report Number: 1917413-2022-00693
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981013
• 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: 11/21/2022

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: 06/30/2023
• Device Catalogue Number: 367846
• Device Lot Number: 2080646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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