MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE 15MG POTASSIUM OXALATE BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367925
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: bd had not received samples, but 11 photos were provided for investigation.The photos were reviewed and the indicated failure mode for foreign matter (hair) was observed.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 foreign matter (hair).Bd was not able to identify a root cause for the indicated failure mode however, there has been increased awareness for cleanliness and reduction of foreign matter in the plant and, several projects are in place that will help reduce the potential of introducing fm into tubes.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® sodium fluoride 15mg potassium oxalate blood collection tubes, the device experienced foreign matter in the tube.The following information was provided by the initial reporter.The customer stated: there is a hair inside the tube.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/3/2021.H.6.Investigation: bd received 1 sample and 11 photos from the customer in support of this complaint.A visual examination of sample and photos was performed and the customer's indicated failure mode of foreign matter (hair) was observed.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.Bd was able to confirm the customer¿s indicated failure mode with the sample and photos provided.Bd was unable to determine a specific root cause however, there has been increased awareness for cleanliness and reduction of foreign matter in the plant and, several projects are in place that will help reduce the potential of introducing fm into tubes.
Event or Problem Description
It was reported when using the bd vacutainer® sodium fluoride 15mg potassium oxalate blood collection tubes, the device experienced foreign matter in the tube.The following information was provided by the initial reporter.The customer stated: there is a hair inside the tube.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE 15MG 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12682416
• Report Number: 1917413-2021-00921
• Device Sequence Number: 4986039
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: 50382903679251
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 12/07/2021

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: 08/31/2022
• Device Model Number: 367925
• Device Catalogue Number: 367925
• Device Lot Number: 1074778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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