MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367001
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	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.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 that an unspecified amount of bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg had "black" foreign matter in the tubes.The following information was provided by the initial reporter: customer complaints seeing black particles in bd 367001 ,lot #321350.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-04-17.H.6.Investigation summary: bd received [5] samples and [4] photos in support of this complaint for catalog 367001, lot number 2321350.The photos were reviewed and the customer¿s indicated failure mode was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for foreign matter with the incident lot was observed.There are black particles on the tube under the label and on the stopper.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.Bd was able to confirm the customer¿s indicated failure mode with the samples and photos provided.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified amount of bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg had "black" foreign matter in the tubes.The following information was provided by the initial reporter: customer complaints seeing black particles in bd 367001 ,lot #321350.

• Brand Name: SEE H.10
• 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 ; 8448235433
• MDR Report Key: 16714772
• Report Number: 1917413-2023-00284
• Device Sequence Number: 1609559
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: (01)50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: 11/30/2024
• Device Model Number: 367001
• Device Catalogue Number: 367001
• Device Lot Number: 2321350
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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