MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES; 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	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was reported that bd vacutainer® trace element serum plus blood collection tubes were giving erroneous results.This occurred on 10 occasions during use.The following information was provided by the initial reporter: material no.368380, batch no.8215763.(2 of 2).It was reported that the amount of aluminum contamination is twice the normal range for patient serum results.The navy trace metals serum tubes are contaminated with aluminum.The amount of contamination is twice the normal range for patient serum results.There are patients that have their aluminum levels tested yearly and their results have gone from being within the normal range to more than twice the normal range.The patient samples are referred to us from all over ontario and i do not have the lot numbers for the tubes that were used.I do not know how the course of treatment was changed based on the erroneous results.
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.Bd acknowledges the customer's experience regarding the indicated failure mode for erroneous results with the incident lot.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.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.
Event or Problem Description
It was reported that bd vacutainer® trace element serum plus blood collection tubes were giving erroneous results.This occurred on 10 occasions during use.The following information was provided by the initial reporter: material no.368380 batch no.8215763.(2 of 2) it was reported that the amount of aluminum contamination is twice the normal range for patient serum results.The navy trace metals serum tubes are contaminated with aluminum.The amount of contamination is twice the normal range for patient serum results.There are patients that have their aluminum levels tested yearly and their results have gone from being within the normal range to more than twice the normal range.The patient samples are referred to us from all over ontario and i do not have the lot numbers for the tubes that were used.I do not know how the course of treatment was changed based on the erroneous results.

• 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: 9273856
• Report Number: 1917413-2019-02305
• Device Sequence Number: 16243101
• 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: 8215763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/04/2019
• 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