MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364305

Device Problem Break (1069)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

It was reported that while using bd vacutainer® blood collection tubes buffered sodium citrate 0.3ml - 0.109m that there was a broken lid/ cap.The following information was provided by the initial reporter: when affixing the inspection barcode, it was found that the cap of the blood collection tube was missing a piece.It should be a product quality problem.Replace immediately and report.No harm was done to the patient.

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.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode of molding defect was observed.Additionally, 100 retention samples from bd inventory were evaluated by visual examination and the issue of molding defect was not observed.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 has been confirmed for the indicated failure mode molding defect.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that while using bd vacutainer® blood collection tubes buffered sodium citrate 0.3ml - 0.109m that there was a broken lid/ cap.The following information was provided by the initial reporter: when affixing the inspection barcode, it was found that the cap of the blood collection tube was missing a piece.It should be a product quality problem.Replace immediately and report.No harm was done to the patient.

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17458030
• MDR Text Key: 320493070
• Report Number: 9617032-2023-01041
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 364305
• Device Lot Number: 3073122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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