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	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.1.Medical device brand name: bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes.H.3.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 that during use with bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes there were low glucose levels.Patient information and incident details were unable to be obtained.This occurred on at least 3 occasions.The following information was provided by the initial reporter: customer reports a constant of discrepant results on glucose levels reporting as "critically low".Customer reports at least 3 incidents this week, but mentions in the past this has also occurred.Issue was isolate to tubes from lot#: 2200163.
Additional Manufacturer Narrative
H.6.Investigation summary: retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to erroneous results were observed.No difficulties were encountered during blood collection and all tubes exhibited proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure (erroneous results- glucose) because the defect was not evident in the testing of the complaint lot samples.Replicates of both retain and control samples tested were acceptable in terms of both precision and accuracy.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 not confirmed with respect to erroneous results- glucose.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to erroneous results 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.
Event or Problem Description
It was reported that during use with bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes there were low glucose levels.Patient information and incident details were unable to be obtained.This occurred on at least 3 occasions.The following information was provided by the initial reporter: customer reports a constant of discrepant results on glucose levels reporting as "critically low".Customer reports at least 3 incidents this week, but mentions in the past this has also occurred.Issue was isolate to tubes from lot#: 2200163.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17580744
• Report Number: 1917413-2023-00820
• Device Sequence Number: 8349325
• Product Code: JKA
• UDI-Device Identifier: 50382903679220
• UDI-Public: 50382903679220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• 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,Followup
• Report Date (Section B): 01/23/2024

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: 11/30/2023
• Device Catalogue Number: 367922
• Device Lot Number: 2200163
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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