MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® 4NC 0.129M 0.4 ML BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367740

Device Problem Material Discolored (1170)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported when using the bd vacutainer® 4nc 0.129m 0.4 ml blood collection tube the shield/cap stopper is different color/shade or faded.The following information was provided by the initial reporter.The customer stated: "he inside of the cap is usually blue but was black in the complaint product.".

• Brand Name: BD VACUTAINER® 4NC 0.129M 0.4 ML BLOOD COLLECTION TUBE
• 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 ; 8015296192
• MDR Report Key: 15664190
• MDR Text Key: 306935788
• Report Number: 9617032-2022-01064
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 367740
• Device Lot Number: 2056023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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