MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367878
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® lithium heparinn (lh) blood collection tubes has issues with clotting.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that lot#: 3111828 with coagulation.They report that " blood that is drawn goes glossy and cannot be used".
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 vacutainer® lithium heparinn (lh) blood collection tubes has issues with hemolysis.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that lot#: 3111828 with coagulation.They report that " blood that is drawn goes glossy and cannot be used".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for hemolysis was observed.Additionally, 100 retention samples from bd inventory were visually inspected with no issues identified.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 has been confirmed for 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.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.B.5.Describe event or problem: it was reported when using the bd vacutainer® lithium heparin (lh) blood collection tubes has issues with hemolysis.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that lot#: 3111828 with coagulation.They report that " blood that is drawn goes glossy and cannot be used".H.6.Imdrf annex a: a0302 - device ingredient or reagent problem (2910).
Event or Problem Description
It was reported when using the bd vacutainer® lithium heparin (lh) blood collection tubes has issues with hemolysis.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that lot#: 3111828 with coagulation.They report that " blood that is drawn goes glossy and cannot be used".

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
• Common Device Name: 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: jo doyka ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18043064
• Report Number: 1917413-2023-01112
• Device Sequence Number: 20700118
• Product Code: JKA
• UDI-Device Identifier: 00382903678785
• UDI-Public: (01)00382903678785
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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,Followup
• Report Date (Section B): 11/28/2023

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: 09/30/2024
• Device Catalogue Number: 367878
• Device Lot Number: 3111828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/07/2023; 11/28/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/13/2023; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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