MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BLOOD COLLECTION TUBE BUFFERED SODIUM CITRATE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 364305

Device Problems Inability to Auto-Fill (1044); Coagulation in Device or Device Ingredient (1096)

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

Event Date 05/07/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E.1.Initial reporter addr 1:(b)(6).

Event Description

It was reported when using the bd vacutainer® blood collection tube buffered sodium citrate had coagulated and the blood could not be inhaled normally.The following information was provided by the initial reporter.The customer stated: when the nurse drew blood from the patient in the morning, it was found that there was no draw inside the blue coagulation test tube, and the blood could not be inhaled normally.The nurse switched to using a syringe for suction and injection, and then completed the blood collection operation normally.No adverse consequences were caused.

Manufacturer Narrative

Investigation summary: bd had not received samples or photos for investigation.Therefore, 20 retention samples from bd inventory were evaluated by functional testing, each drawn with deionized water, and no issues were observed relating to low draw volume as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode low draw volume.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".

Event Description

It was reported when using the bd vacutainer® blood collection tube buffered sodium citrate had coagulated and the blood could not be inhaled normally.The following information was provided by the initial reporter.The customer stated: when the nurse drew blood from the patient in the morning, it was found that there was no draw inside the blue coagulation test tube, and the blood could not be inhaled normally.The nurse switched to using a syringe for suction and injection, and then completed the blood collection operation normally.No adverse consequences were caused.

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBE BUFFERED SODIUM CITRATE
• 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 ; 8448235433
• MDR Report Key: 17239080
• MDR Text Key: 318271159
• Report Number: 9617032-2023-00820
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903643054
• UDI-Public: 50382903643054
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013971
• 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: 07/07/2023

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: 11/30/2023
• Device Model Number: 364305
• Device Catalogue Number: 364305
• Device Lot Number: 3030795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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