MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367964
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	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes, there are high ast results in an unspecified number of tubes across multiple lot numbers.Lot numbers were not provided.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting that they had continuous issue with high ast's in pst tubes.We are experiencing high ast across all lots, we have been having an issue since spring 2022.How many individuals were affected 20-50 patients per day.".
Additional Manufacturer Narrative
D1: medical device brand name: bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes.H.6.Investigation summary: material #: 367964 lot/batch #: 3016665 bd had received 5 samples and no photos for evaluation.The customer samples along with 100 retention samples of the incident lot from bd inventory were evaluation and no issues were observed.A clinical evaluation was not required for this erroneous results complaint as information regarding this situation is outlined in the limitations section of the ifu (instructions for use).For tubes subjected to centrifugation to generate plasma or serum for testing, standard processing conditions do not necessarily completely sediment all cells, whether or not barrier gel is present.Cell-based metabolism, as well as natural degradation ex vivo, can continue to affect serum/plasma analyte concentrations/activities after centrifugation.Separated plasma samples in particular, will have a gradient of cells and platelets present after centrifugation.The presence of cells and platelets in the plasma may lead to increased variability and/or instability of certain analytes that are involved in cell/platelet-mediated metabolic processes and/or are present in higher concentrations in cells or platelets.Analytes that may be affected include aspartate aminotransferase (ast), glucose, inorganic phosphorus, lactate dehydrogenase and potassium.The magnitude of such effects may vary depending on several factors, including whether the plasma is aliquoted or remains in the primary tube, sample agitation, and time.Analyte stability should be evaluated for the storage containers and conditions of each laboratory 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-ast.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: SEE H.10
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17952354
• Report Number: 1917413-2023-01025
• Device Sequence Number: 6790129
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/05/2023

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: 01/31/2024
• Device Catalogue Number: 367964
• Device Lot Number: 3016665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown