MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366643
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported prior to using bd vacutainer® k2 edta (k2e) plus blood collection tubes that there was foreign matter in the tube and a cracked lid.There was no health impact or consequences reported.
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 3170109.D4.Medical device expiration date: 2024-jun-30.H4.Device manufacture date: 2023-jun-19.H.6.Investigation summary: bd japan received 10 samples (lot 3254840 and lot 3176109), and 4 photographs were attached.Evaluation of both indicates partially fading print and 1 cracked hemoguard shield (lot 3163221).Embedded fm was not observed.Evaluation of the 100 retained samples from each lot number identified no further examples of this defect.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.Bd was able to confirm the customer¿s indicated failure modes ¿ printing defect, cracked shield with the photographs and samples provided.Bd was unable to confirm the customer¿s indicated failure mode ¿ embedded fm based on the evaluation of the evidence provided.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.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES
• Common Device Name: 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18705380
• Report Number: 9617032-2024-00188
• Device Sequence Number: 6234812
• Product Code: GIM
• UDI-Device Identifier: 50382903666435
• UDI-Public: (01)50382903666435
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2024

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 366643
• Device Lot Number: 3163221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown