MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367873

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 07/17/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown.The date received by manufacturer has been used for this field.H.6 investigation summary: bd had not received samples, but 1 photo was provided for investigation.Evaluation of the photo indicated a tube with larger than normal droplets of additive on the tube wall.Due to this, the additive has yellowed slightly on irradiation.This is recognized to be an aesthetic defect with no impact on the efficacy of the tube.Additionally, 100 retained samples were visually inspected, and no additive abnormality was found.Bd was able to duplicate and confirm the customers¿ failure mode from the photo received.Bd was not able to identify a root cause for the indicated failure mode.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 able to be confirmed for the indicated failure mode.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." h3 other text : see h.10.

Event Description

It was reported that while using the bd vacutainer® k2e 10.8mg plus blood collection tubes that there was foreign matter in tube; biological and nonbiological.The following information was provided by the initial reporter: one of the sites have reported an issue with an individual bd purple top tube.The hcp took a new pack out to use and found one of the tubes was contaminated.Lot number 3093802.

• Brand Name: BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES
• 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: 17486909
• MDR Text Key: 321528702
• Report Number: 9617032-2023-01066
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/31/2023

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 Catalogue Number: 367873
• Device Lot Number: 3093802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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