MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2E / K2 EDTA BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368171

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/02/2022

Event Type  malfunction  

Manufacturer Narrative

D4.Medical device lot #: 2292116.D4.Medical device expiration date: 2024-02-29.H4.Device manufacture date:2 022-10-19.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd vacutainer® k2e / k2 edta blood collection tubes that there was mold present.The following information was provided by the initial reporter: complaint lilac tube with fungus.- fungus inside the tube.Delay in processes.

Event Description

It was reported that while using the bd vacutainer® k2e / k2 edta blood collection tubes that there was mold present.The following information was provided by the initial reporter: complaint lilac tube with fungus.- fungus inside the tube.Delay in processes.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-04-14.H.6.Investigation summary: bd received 65 customer samples from lot [2259110], 89 customer samples from lot [ 2292116] and [6] photos for investigation.Visual examination of samples and photos was performed and revealed additive abnormality.Bd was able to confirm the customer¿s indicated failure mode with the samples and photos provided.The device history records for both lots 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.

• Brand Name: BD VACUTAINER® K2E / K2 EDTA BLOOD COLLECTION TUBES
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16677689
• MDR Text Key: 312862595
• Report Number: 1917413-2023-00260
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 368171
• Device Lot Number: 2259110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1