MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365047
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter state: address information was not able to be obtained, therefore, nj was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® barricor¿ lithium heparin plasman blood collection tubes, the device experienced foreign matter within the tube, along with erroneous results.The following information was provided by the initial reporter.The customer stated: it was reported that customer reports trace-element contamination from serum collection tubes 367983 and 365047."the issue was reported by key-young choe in a 2021 paper in the journal of trace elements in medicine and biology titled "evaluation of trace-element contamination from serum collection tubes used by the california biobank program." the authors performed leaching tests for ssts with di water that revealed detectable levels of cr, mn, co, sr, sb, pb, and u were measured, while sb was elevated.Tests of psts also revealed contamination of mn, co, sr, and sb, with co and sr being much higher than those found from ssts.Trace-element measurements from 200 samples archived by the california biobank program using ssts suggest that sst contamination was negligible for se and mo.For mn, as, sr, cd, and hg, based on their leaching results, only a fraction of these samples had considerably high concentrations (e.G., > 10×) compared to the contamination from the sst.For cr, co, sb, tl, pb, and u, analyte levels were too low in most samples compared to the contamination from the ssts.The authors expressed caution for using sst or pst tubes for trace element analysis, with a slight preference for using pst for cr, as, cd, hg, tl, pb, and u.".
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.The reported issue in this publication refers to a trace element contamination found in bd tube pms plh 13x100 5.5 plbl lme.The instructions for use for this product do not include data for trace element analysis.Our trace element tubes are specifically designed for this purpose and have supporting data to that effect.This is considered an off label use of this product.Unless they perform a specific validation for their intended use, our trace element tubes are recommended.This complaint is unable to be confirmed.
Event or Problem Description
It was reported when using the bd vacutainer® barricor¿ lithium heparin plasman blood collection tubes, the device experienced foreign matter within the tube, along with erroneous results.The following information was provided by the initial reporter.The customer stated: it was reported that customer reports trace-element contamination from serum collection tubes 367983 and 365047."the issue was reported by key-young choe in a 2021 paper in the journal of trace elements in medicine and biology titled "evaluation of trace-element contamination from serum collection tubes used by the california biobank program." the authors performed leaching tests for ssts with di water that revealed detectable levels of cr, mn, co, sr, sb, pb, and u were measured, while sb was elevated.Tests of psts also revealed contamination of mn, co, sr, and sb, with co and sr being much higher than those found from ssts.Trace-element measurements from 200 samples archived by the california biobank program using ssts suggest that sst contamination was negligible for se and mo.For mn, as, sr, cd, and hg, based on their leaching results, only a fraction of these samples had considerably high concentrations (e.G., > 10×) compared to the contamination from the sst.For cr, co, sb, tl, pb, and u, analyte levels were too low in most samples compared to the contamination from the ssts.The authors expressed caution for using sst or pst tubes for trace element analysis, with a slight preference for using pst for cr, as, cd, hg, tl, pb, and u.".

• Brand Name: BD VACUTAINER® BARRICOR¿ LITHIUM HEPARIN PLASMAN 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14402951
• Report Number: 9617032-2022-00473
• Device Sequence Number: 17544352
• Product Code: JKA
• UDI-Device Identifier: 00382903650477
• UDI-Public: 00382903650477
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160657
• 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): 07/22/2022

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: 365047
• Device Lot Number: UNKNOWN
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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