MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367925
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tube there was mix of product types in a pack.The following information was provided by the initial reporter.The customer stated: "today, the supply team reported this deviation: in a rack of gray cap tubes, potassium oxalate / sodium fluoride, 2 tubes from another batch were found that were already expired.".
Additional Manufacturer Narrative
H.6.Investigation summary: no samples and 3 photos were returned by the customer in support of this complaint.The photos were evaluated and show tubes from catalog 367925 with lots 1350365 and 0345803.Catalog 367925, lot 0345803 was manufactured in 01feb2021 (expired).Catalog 367925, lot 1350365 was manufactured in 01jan2022.Per procedure, line clearance, each individual manufacturing station/work center is cleared prior to commencing manufacture of the next scheduled production batch through that station/work center.These two lots were produced on the same line; however, the manufacturing dates are 11 months apart.With our current line clearance procedure, mixed product could not have come from the manufacturing site.Bd was able to confirm the customer¿s indicated failure mode with the photos provided; however, the mixed product did not come from the manufacturing plant in this manner.The exact cause for the customer¿s failure mode could not be determined with the investigation.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tube there was mix of product types in a pack.The following information was provided by the initial reporter.The customer stated: "today, the supply team reported this deviation: in a rack of gray cap tubes, potassium oxalate / sodium fluoride, 2 tubes from another batch were found that were already expired.".

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15473337
• Report Number: 1917413-2022-00598
• Device Sequence Number: 11471294
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 05/31/2023
• Device Model Number: 367925
• Device Catalogue Number: 367925
• Device Lot Number: 1350365
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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