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

Catalog Number	368884
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® lh (lithium heparin) 68 i.U.Plus blood collection tubes an unspecified number of tubes pushed off the non-patient acquisition needle end during collection.There was no health impact or consequence reported.
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d4.Medical device lot #: 3296356 d4.Medical device expiration date: 28-feb-2025 h4.Device manufacture date: 23-oct-2023 d4.Medical device lot #: 3275230 d4.Medical device expiration date: 31-jan-2025 h4.Device manufacture date: 02-oct-2023 d4.Medical device lot #: 4044594 d4.Medical device expiration date: 31-may-2025 h4.Device manufacture date: 13-feb-2024 investigation summary: bd received (b)(4) samples of lot 3296356, (b)(4) samples of lot 3275230, and 1 sample of lot 4044594 from the customer in support of this complaint.All 11 customer returned samples were evaluated via functional testing and none of the 11 tubes were pushed off the needles.The indicated failure mode for tube push off with the incident lot was not observed as all product specifications were met.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 tube push off.Bd was not able to identify a root cause for the indicated failure mode.This type of defect is generally associated with the acquisition device used, and in particular the resilience of the sleeve and/or the level of lubrication of the non-patient end needle.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® LH (LITHIUM HEPARIN) 68 I.U. 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: 19824445
• Report Number: 9617032-2024-01115
• Device Sequence Number: 21003555
• Product Code: JKA
• UDI-Device Identifier: 30382903688846
• UDI-Public: (01)30382903688846
• Combination Product (Y/N): N
• Initial Reporter Country: FO
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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 Catalogue Number: 368884
• Device Lot Number: SEE H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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