MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® SST¿ - AMBER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365978
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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
It was reported when using the bd microtainer® sst¿ - amber tube are hemolyzing.There was no report of impact to patient or user.
Event or Problem Description
It was reported when using the bd microtainer® sst¿ - amber tube are hemolyzing.There was no report of impact to patient or user.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 9 samples for investigation.Customer samples and retention samples from the same lot were visually inspected with no issues observed.Complaints for sample quality are under statistical control for the month of (b)(6) 2023.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 a sample quality issue(hemolysis).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.The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes d9: returned to manufacturer on: 31-oct-2023/.

• Brand Name: BD MICROTAINER® SST¿ - AMBER
• 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: 18131545
• Report Number: 2618282-2023-00100
• Device Sequence Number: 6365086
• Product Code: JKA
• UDI-Device Identifier: 50382903659789
• UDI-Public: (01)50382903659789
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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
• Operator of Device: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 365978
• Device Lot Number: 2339694
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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