MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367324
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fpa.Common device name: intravascular administration set.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 during use with 2 bd vacutainer® push button blood collection set there was insufficient blood flow through the device.There was no patient impact.The following information was provided by the initial reporter: the expectation is when you are using the butterfly needle, the attached blood drawing tube is attached to the adapter and the tubes fill without any issues, what we are seeing is that the blood is seen in the tubing and going very slow.
Event or Problem Description
It was reported that during use with 2 bd vacutainer® push button blood collection set there was insufficient blood flow through the device.There was no patient impact.The following information was provided by the initial reporter: the expectation is when you are using the butterfly needle, the attached blood drawing tube is attached to the adapter and the tubes fill without any issues, what we are seeing is that the blood is seen in the tubing and going very slow.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 10 samples and 1 photo for investigation.The photo shows the product packaging.The customer samples were evaluated by visual examination and functional draw testing and the indicated failure modes for leakage and insufficient flow with the incident lot was not observed as all product specifications were met.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 is unable to be confirmed for the indicated failure mode leakage and insufficient flow.Bd was not able to identify a root cause for the indicated failure mode.The following fields were updated due to additional information: d9: device available for evaluation:  yes d9: returned to manufacturer on:  2023-05-23 h3 other text : see h.10.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17061475
• Report Number: 1710034-2023-00612
• Device Sequence Number: 17437809
• Product Code: JKA
• UDI-Device Identifier: 50382903673242
• UDI-Public: (01)50382903673242
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K030573
• 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): 07/25/2023

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: 10/31/2024
• Device Model Number: 367324
• Device Catalogue Number: 367324
• Device Lot Number: 2306034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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