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	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
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
It was reported that during use with the bd vacutainer® lh (lithium heparin) 68 i.U.Plus blood collection tubes, samples clotted.This occurred 10 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from french: these tubes are centrifuged, then scanned and photographed then they are sent to our analytical lines, where the machine detects a ¿clot¿ so nothing is taken or analyzed and a technical alarm is generated which generates significant delays for these samples.When we collected the tube about thirty minutes later by hand, the foam was still present.For your information, we work with (b)(6), and our tubes circulate on 5-position racks.The other tubes in the rack did not have this foam, so a jolt on the conveyor after centrifugation seems unlikely to me as well.Are there clots or fibrin found in the samples or just the instrument indicating ¿clot¿?: the sample is foaming/showing bubbles on top of the plasma.These bubbles are perceived as a clot by the instrument.When it states: ¿the foam was still present¿ ¿ is this the issue that needs to be reported?: are there bubbles in the sample?: the customer means the bubbles stayed present after centrifugation.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 11-nov-2023.H.6.Investigation summary: bd received 1 contaminated sample and 2 photos for investigation.The contaminated sample was immediately discarded.The photos were reviewed and the indicated failure mode for poor plasma (bubbles in plasma) was observed.Additionally, 10 retention samples from bd inventory, were evaluated by functional testing and no bubbles were observed.Bubbles at the top of plasma can occur due to vigorous shaking during specimen handling.If bubbles are observed, attempt to test the tube again.Bd does not have data on the impact of bubbles on test results.Complaints for sample quality are under statistical control for the month of october 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 the indicated failure mode poor plasma (bubbles in plasma) based on the photos provided.Bd was not able to identify an exact 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.
Event or Problem Description
It was reported that during use with the bd vacutainer® lh (lithium heparin) 68 i.U.Plus blood collection tubes, samples clotted.This occurred 10 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from french: these tubes are centrifuged, then scanned and photographed then they are sent to our analytical lines, where the machine detects a ¿clot¿ so nothing is taken or analyzed and a technical alarm is generated which generates significant delays for these samples.When we collected the tube about thirty minutes later by hand, the foam was still present.For your information, we work with roche automats, and our tubes circulate on 5-position racks.The other tubes in the rack did not have this foam, so a jolt on the conveyor after centrifugation seems unlikely to me as well.Are there clots or fibrin found in the samples or just the instrument indicating ¿clot¿? the sample is foaming/showing bubbles on top of the plasma.These bubbles are perceived as a clot by the instrument.When it states: ¿the foam was still present¿ ¿ is this the issue that needs to be reported? are there bubbles in the sample? the customer means the bubbles stayed present after centrifugation.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18007771
• Report Number: 9617032-2023-01551
• Device Sequence Number: 6643486
• Product Code: JKA
• UDI-Device Identifier: 30382903688846
• UDI-Public: (01)30382903688846
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: 07/31/2024
• Device Catalogue Number: 368884
• Device Lot Number: 3087975
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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