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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® trace element serum plus blood collection tubes experienced erroneous results.The following information was provided by the initial reporter.The customer stated: "unexpected higher than usual zinc values in veterinary samples.For 8 weeks, they see elevates zinc values.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-06-11.Investigation summary: bd received 10 samples for investigation.The customer samples were evaluated along with retention samples of the incident lot selected from bd inventory.The samples were tested and no issues relating to erroneous results - elevated zinc values were observed.We do not have the capability for veterinary clinical investigations, therefore this product was tested with human subjects for this evaluation.There were no difficulties encountered during collection.Bd was unable to duplicate the customer¿s indicated failure mode, elevated zinc values.The submitted customer and retain lots (including a control lot) were referred to quest diagnostics laboratories for zinc analysis.All samples yielded results within the referring laboratory¿s reference range of 60-130 mcg/dl.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode erroneous results - elevated zinc values.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to erroneous results - elevated zinc values were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd vacutainer® trace element serum plus blood collection tubes experienced erroneous results.The following information was provided by the initial reporter.The customer stated: "unexpected higher than usual zinc values in veterinary samples.For 8 weeks, they see elevates zinc values.".

• 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: 11891161
• Report Number: 1917413-2021-00449
• Device Sequence Number: 1266134
• Product Code: JKA
• UDI-Device Identifier: 50382903683807
• UDI-Public: 50382903683807
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K041071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/09/2021

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 Expiration Date: 08/31/2021
• Device Model Number: 368380
• Device Catalogue Number: 368380
• Device Lot Number: 0227230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 10/10/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1