MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H10; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367925
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes are clotting.The samples had to be recollected, but no patient impact was reported.
Additional Manufacturer Narrative
D1: medical device brand name: bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 313604, d4.Medical device expiration date: 30-sep-2024, h4.Device manufacture date: 16-may-2023, d4.Medical device lot #: 3222754, d4.Medical device expiration date: 31-jan-2025, h4.Device manufacture date: 10-aug-2023.
Event or Problem Description
It was reported by the customer that the bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes are clotting.The samples had to be recollected, but no patient impact was reported.
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: d.4.Device available for eval: yes.D.4.Returned to manufacturer on: 29-feb-2024.H.6.Investigation summary: bd received five (5) samples of each lot and one (1) photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for clotted samples was observed.Additionally, the customer samples were evaluated by visual examination and no issues were observed.Complaints for sample quality are under statistical control for the month of december 2023.At this time, further testing is not indicated.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 has been confirmed for the indicated failure mode of clotted samples.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.

• Brand Name: SEE H10
• 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: 18539870
• Report Number: 1917413-2023-01357
• Device Sequence Number: 15352591
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: (01)50382903679251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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 Catalogue Number: 367925
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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