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

Catalog Number	367925
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	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while testing with bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes samples showed hemolysis.No patient impact reported.The following information was provided by the initial reporter: the samples are hemolyzing.
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D1.Bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes d4.Medical device lot #: 2132113 d4.Medical device expiration date: 31-10-2023 h4.Device manufacture date: 12-05-2022 d4.Medical device lot #: 2292100 d4.Medical device expiration date: 31-03-2024 h4.Device manufacture date: 19-10-2022 e.1 - (b)(6) h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: one photo was provided for investigation.The photo was reviewed and the indicated failure mode for hemolysis was observed.Additionally, retention samples from bd inventory for both lots were visually inspected with no issues observed.Complaints for sample quality are under statistical control for the month of october 2023.At this time, further testing is not indicated.Based on a review of the device history record for the incident lot #'s, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for hemolysis based on the photo provided.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.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported while testing with bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes samples showed hemolysis.No patient impact reported.The following information was provided by the initial reporter: the samples are hemolyzing.

• 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: 18097184
• Report Number: 1917413-2023-01128
• Device Sequence Number: 14877272
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: (01)50382903679251
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: Health Professional
• Device Catalogue Number: 367925
• Device Lot Number: SEE H.10
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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