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

Catalog 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	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes had foreign matter found between the package film and the blood collection tube.The following information was provided by the initial reporter: the customer reported that a hair-like foreign matter was found between the package film and the blood collection tube.Foreign matter was detected by visual inspection before use.
Additional Manufacturer Narrative
Initial reporter facility name: (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.
Event or Problem Description
It was reported that before use bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes had foreign matter found between the package film and the blood collection tube.The following information was provided by the initial reporter: the customer reported that a hair-like foreign matter was found between the package film and the blood collection tube.Foreign matter was detected by visual inspection before use.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.It was determined by management that this is not a product complaint, therefore, this is not considered to be a reportable malfunction.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17943737
• Report Number: 1917413-2023-01029
• Device Sequence Number: 7645345
• 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,Followup
• Report Date (Section B): 10/25/2023

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: 03/31/2024
• Device Catalogue Number: 367963
• Device Lot Number: 3074303
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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