MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® SODIUM HEPARINN (NH) 75 USP UNITS BLOOD COLLECTION TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367871
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	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device expiration date: unknown.H4.Medical device manufacture date: unknown.Investigation summary: bd did not receive samples or photos 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.Based on the information provided, the reported elevated sodium results occurred when sodium heparin tubes were collected and processed instead of lithium heparin tubes.The sodium heparin tube includes diagonal hash marks printed on the tube label to visually differentiate it from lithium heparin tubes.However, the customer applied their patient identification label over the bd tube label at the time of collection, which obscured these visual identifiers and prevented differentiation of the tube additive.Bd recommends that customer applied labels be placed in a manner that does not obscure or block bd provided tube labeling and visual identifiers, as these are critical for correct tube identification and appropriate use.This complaint is unable to be confirmed.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.
Event or Problem Description
It was reported while using bd vacutainer® sodium heparinn (nh) 75 usp units blood collection tubes, erroneous sodium results were observed on one patient after using the wrong green top tube.Sodium heparin tubes were collected and processed instead of lithium heparin tubes.The customer applied their patient identification label over the bd tube label at the time of collection.Patient was not treated for elevated sodium levels.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® SODIUM HEPARINN (NH) 75 USP UNITS BLOOD COLLECTION TUBES
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24823508
• Report Number: 1917413-2026-00256
• Device Sequence Number: 9532164
• Product Code: JKA
• UDI-Device Identifier: 30382903678717
• UDI-Public: (01)30382903678717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944566
• 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): 03/26/2026

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 Catalogue Number: 367871
• Device Lot Number: UNKNOWN
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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