MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367963
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	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tube there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "foreign matter was found inside the tube.".
Additional Manufacturer Narrative
Investigation summary: 1 sample and 3 photos were returned by the customer in support of this complaint.A visual examination of photos was performed and the customer's indicated failure mode of foreign matter was observed on the inside of the tube.There is a loose piece of hemogard closure material in the gel.Bd was able to confirm the customer¿s indicated failure mode with the sample and photos provided.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 foreign matter into tubes.Based on an evaluation of frequency it was determined that no corrective action is required at this time.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.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 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: 13027592
• Report Number: 1917413-2021-01066
• Device Sequence Number: 5040944
• Product Code: JKA
• UDI-Device Identifier: 50382903679633
• UDI-Public: 50382903679633
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/24/2021

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: 06/30/2022
• Device Model Number: 367963
• Device Catalogue Number: 367963
• Device Lot Number: 1165677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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