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

Catalog Number	367922
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	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes, one patient had discrepant lactic acid results.The patient's sample was recollected.There was no health impact or consequences reported.The following information was provided by the initial reporter: customer states the specimen was initially drawn from the top of the hand using a wing-set collection set.The patient was a dialysis patient.The initial result was 5.3.The sample was re-collected from the patient the same day and re-run (within 1-2 hours after first sample) and the lactic acid result was 1.45.
Additional Manufacturer Narrative
D1.Medical device brand name: bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g.5.Pma / 510(k)#: k901449.H.6 investigation summary: (b)(4) retention samples from bd inventory were visually inspected with no issues identified.Further clinical testing could not be conducted as certain assays, in this case lactic acid analyte testing, are not validated in bd clinical laboratory protocols.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 erroneous results (lactic acid).Bd was not able to identify a root cause for the indicated failure mode.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.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18789669
• Report Number: 1917413-2024-00141
• Device Sequence Number: 7832159
• Product Code: JKA
• UDI-Device Identifier: 00382903679225
• UDI-Public: (01)00382903679225
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/17/2024

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: 01/31/2025
• Device Catalogue Number: 367922
• Device Lot Number: 3257749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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