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

Catalog Number	368380
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that the bd vacutainer® trace element serum plus blood collection tube has been found experiencing erroneous results during use.The following has been provided by the initial reporter: it was reported that patients results tested were contaminated with aluminum.Customer reports that this issue occurred today but has noticed over the year that her patients results have shifted up, patients results have been affected.She does not know the lot number since they are just sent to her for testing.There are no unused samples to be sent in.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos from the customer facility 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.Bd recommends the use of our bd vacutainer® trace elements tube (ref 368520 or 368521) for analysis of the following: manganese (mn), lead (pb), iron (fe), copper (cu), chromium (cr), cadmium (cd), arsenic (as), antimony (sb), magnesium (mg), calcium (ca), zinc (zn), selenium (se), mercury (hg).We have not validated any of the bd collection tubes for aluminum testing.A review of specimen handling parameters should be reviewed for this tube type.H3 other text : see section h.10.
Event or Problem Description
It has been reported that the bd vacutainer® trace element serum plus blood collection tube has been found experiencing erroneous results during use.The following has been provided by the initial reporter: it was reported that patients results tested were contaminated with aluminum.Customer reports that this issue occurred today but has noticed over the year that her patients results have shifted up, patients results have been affected.She does not know the lot number since they are just sent to her for testing.There are no unused samples to be sent in.

• Brand Name: BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBE
• 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: 9266755
• Report Number: 1917413-2019-02294
• Device Sequence Number: 14031897
• Product Code: JKA
• UDI-Device Identifier: 50382903683807
• UDI-Public: 50382903683807
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 368380
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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