MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBES WITH K2E (K2EDTA); BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	36597499
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd microtainer® tubes with k2e (k2edta) an unspecified number of tubes were missing additive causing clotting within the tubes.Sample recollection occurred.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Pt 2 of 2.It was reported when using the bd microtainer® tubes with k2e (k2edta) an unspecified number of tubes were missing additive causing clotting within the tubes.Sample recollection occurred.
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 13-may-2024.B.5.Describe event or problem: patient 2 of 2 it was reported when using the bd microtainer® tubes with k2e (k2edta) an unspecified number of tubes were missing additive causing clotting within the tubes.Sample recollection occurred.H.6.Investigation summary: bd specimen management received two-hundred and five (205) unused customer representative samples from material: 36597499 lot: 3321363 for evaluation.All samples were evaluated for visual presence of additive with acceptable results.Fifteen (15) samples representing each solution dispense position that was present in the customer samples were evaluated for quantity of additive.All tested sampleswere found to comply with specifications.Additionally, fifty (50) retention samples of each lot from bd inventory were evaluated by visual examination and no issues were observed.Fifteen (15) retention samples of each lot were evaluated by functional testing and no issues were observed relating to insufficient additive quantity as all samples met specifications.Complaints for sample quality are under statistical control for the month of april 2024.At this time, further testing is not indicated.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 unable to be confirmed for the indicated failure mode of clotting.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.Bd quality will continue to monitor sample quality complaints.

• Brand Name: BD MICROTAINER® TUBES WITH K2E (K2EDTA)
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19203595
• Report Number: 2618282-2024-00033
• Device Sequence Number: 15471780
• Product Code: JKA
• UDI-Device Identifier: 30382903659747
• UDI-Public: (01)30382903659747
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: NA
• 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,Followup
• Report Date (Section B): 05/07/2024

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: 09/30/2024
• Device Catalogue Number: 36597499
• Device Lot Number: 3108863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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