MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368380
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	05/11/2020
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.Device manufacture date: unknown.(b)(4).Investigation summary: clsi guidelines dictate the cap color, specifically with trace element to be royal blue.Bd understands the lack of distinction between the tubes and will take into consideration all product suggestions.
Event or Problem Description
It was reported before use the customer had difficulty with the bd vacutainer® trace element serum plus blood collection tubes in distinguishing between the k2edta and serum clot activator (silicone coated) tubes which results in putting the specimen in the wrong tube.The following information was provided by the initial reporter: the customer stated "when completing trace metal testing they have a difficult time with the collecting sample and using the correct royal blue tube." customer states "its difficult to differentiate between edta and tubes with no additive.Clinicians look at the cap and do not pay attention to the label on the side of the tube." the lab has to cancel tests and request redraws because the whole blood sample was drawn in the silicone coated tube and clotted prior to reaching the lab for trace metal analysis.

• Brand Name: BD VACUTAINER TRACE ELEMENT SERUM PLUS 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: 10128736
• Report Number: 1917413-2020-00485
• Device Sequence Number: 14249136
• Product Code: JKA
• UDI-Device Identifier: 50382903683807
• UDI-Public: 50382903683807
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2020

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: Health Professional
• Device Model Number: 368380
• Device Catalogue Number: 368380
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/08/2020
• 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