MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES; EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT

Catalog Number	368884
Medical Device Problem Codes	Difficult to Insert (1316); Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using an unspecified number of bd vacutainer® lh (lithium heparin) 68 i.U.Plus blood collection tubes, the device pushed off the connected acquisition device and filling was incomplete.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for investigation.Therefore, (b)(4) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to tube push off or underfill as all samples met specifications.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 modes push off and underfill.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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes h.3 device eval by manufacturer? yes d9: returned to manufacturer on: 20-nov-2024.Investigation summary bd received one hundred (100) samples for investigation.Twenty (20) returned samples and twenty (20) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to tube push off or underfill as all samples met specifications.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 modes push off and underfill.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.
Event or Problem Description
It was reported when using an unspecified number of bd vacutainer® lh (lithium heparin) 68 i.U.Plus blood collection tubes, the device pushed off the connected acquisition device and filling was incomplete.There were no health consequences or impacts reported.

• Brand Name: BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES
• Common Device Name: EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT
• 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: 20724658
• Report Number: 9617032-2024-01804
• Device Sequence Number: 3850389
• Product Code: JKA
• UDI-Device Identifier: 30382903688846
• UDI-Public: (01)30382903688846(11)240430(17)250831(10)4121216
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: 08/31/2025
• Device Catalogue Number: 368884
• Device Lot Number: 4121216
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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