MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367341
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: d.2.Common device name: intravascular administration set.D.2.Medical device type: fpa.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set there was air bubbles forming in the tubing and preventing the tubes from filling properly.The following information was provided by the initial reporter.The customer stated: there are air bubbles in the tube before blood gets to hub or during transfer without the needle leaving the vein.It runs to the hub and eventually into collection tube, then the blood either slows down or stops completely.
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set there was air bubbles forming in the tubing and preventing the tubes from filling properly.The following information was provided by the initial reporter.The customer stated: "there are air bubbles in the tube before blood gets to hub or during transfer without the needle leaving the vein.It runs to the hub and eventually into collection tube, then the blood either slows down or stops completely.".
Additional Manufacturer Narrative
H.6.Investigation summary: a review of the dhr could not be performed as the batch number is unknown.1 customer photo was received for review and evaluation.As no customer samples were received the scope of this investigation is limited.The one customer photo shows the device packaging but does not show the reported defect.Therefore, this complaint cannot be confirmed based on the customer photo provided.Bd is unable to confirm the customer¿s reported failure mode of air bubbles based on customer photo analysis.Retains cannot be tested as the batch number is unknown.Due to an unknown batch number and the unavailability of customer samples, the root cause is indeterminate.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for monitoring of current trends.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.1.Medical device serial #: lot/batch #: (b)(6).H.6.Imdrf annex b grid : b01 - testing of actual/suspected device d9: device available for evaluation:  yes d9: returned to manufacturer on: 2023-07-21.Materials information : d.1.Medical device expiration date: 2024-11-30.H.1.Device manufacture date: 2022-12-07.H.6.Investigation summary: bd received 10 samples for investigation.The samples were evaluated by functional draw testing and the indicated failure mode for air bubbles 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 air bubbles.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set there was air bubbles forming in the tubing and preventing the tubes from filling properly.The following information was provided by the initial reporter.The customer stated: "there are air bubbles in the tube before blood gets to hub or during transfer without the needle leaving the vein.It runs to the hub and eventually into collection tube, then the blood either slows down or stops completely.".

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16727184
• Report Number: 1024879-2023-00217
• Device Sequence Number: 15482722
• Product Code: JKA
• UDI-Device Identifier: 50382903673419
• UDI-Public: 50382903673419
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,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: 11/30/2024
• Device Model Number: 367341
• Device Catalogue Number: 367341
• Device Lot Number: 2341571
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 07/25/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 04/26/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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