MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	366480
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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.(b)(4).
Event or Problem Description
It was reported that several trace elements leach out at greater concentrations than claimed in ifu with a bd vacutainer® sodium heparin (nh) blood collection tubes.The following information was provided by the initial reporter: (2 of 2 complaints).It is reported in study that tubes have issues for a variety of elements claimed on the ifu.Additionally, on 2020-08-31 the bd tech provided the following additional information: spoke to customer, - "internal post-marketing surveillance identified a clinical biochemistry article saying that a specific lot of our royal blue plastic trace element tubes leaches out several trace elements at concentrations greater than we claim, and that our glass sodium heparin tube also leaches out trace elements.I emailed ms.Rosa saying i reviewed the article, identified the lot number of the plastic tube but could not verify the same specific trace metals she did (although several trace metals had been reported as elevated in table 2).I also noted that table 3 reported 5 years of testing 6 different lot numbers of both the plastic trace metal tube and the glass sodium heparin tube, but did not give the other 5 lot numbers for plastic, or any lot numbers for glass.I'm also not aware that bd makes specific claims for suitability of glass sodium heparin tubes for trace metal analysis.".
Event or Problem Description
It was reported that several trace elements leach out at greater concentrations than claimed in ifu with a bd vacutainer® sodium heparin (nh) blood collection tubes.The following information was provided by the initial reporter: (2 of 2 complaints) it is reported in study that tubes have issues for a variety of elements claimed on the ifu.Additionally, on 2020-08-31 the bd tech provided the following additional information: spoke to customer, - "internal post-marketing surveillance identified a clinical biochemistry article saying that a specific lot of our royal blue plastic trace element tubes leaches out several trace elements at concentrations greater than we claim, and that our glass sodium heparin tube also leaches out trace elements.I emailed ms.Rosa saying i reviewed the article, identified the lot number of the plastic tube but could not verify the same specific trace metals she did (although several trace metals had been reported as elevated in table 2).I also noted that table 3 reported 5 years of testing 6 different lot numbers of both the plastic trace metal tube and the glass sodium heparin tube, but did not give the other 5 lot numbers for plastic, or any lot numbers for glass.I'm also not aware that bd makes specific claims for suitability of glass sodium heparin tubes for trace metal analysis.".
Additional Manufacturer Narrative
Investigation summary bd had not received samples or photos from the customer 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.

• Brand Name: BD VACUTAINER SODIUM HEPARIN (NH) 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
• MDR Report Key: 10551311
• Report Number: 1917413-2020-00829
• Device Sequence Number: 19149964
• Product Code: JKA
• UDI-Device Identifier: 50382903664806
• UDI-Public: 50382903664806
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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 Model Number: 366480
• Device Catalogue Number: 366480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other