MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	367354
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2b medical device type: one additional code applies; jka.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 while using two bd vacutainer® push button blood collection set with pre-attached holder, the needle got stuck; the customer couldn't press up.No patient or user impact reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H3: device eval by manufacturer? yes.D9: returned to manufacturer on: 12-mar-2025.Investigation summary: bd received three (3) samples for investigation.The samples were subjected to retraction lockout testing, and the indicated failure mode for difficult to activate with the incident lot was not observed.Additionally, 30 retention samples from bd inventory were subjected to retraction lockout testing and no issues were observed relating to difficult to activate as all samples met specifications.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 of difficult to activate.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".
Event or Problem Description
It was reported that while using two bd vacutainer® push button blood collection set with pre-attached holder, the needle got stuck; the customer couldn't press up.No patient or user impact reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21551258
• Report Number: 1024879-2025-00270
• Device Sequence Number: 4642999
• Product Code: FPA
• UDI-Device Identifier: 00382903673544
• UDI-Public: (01)00382903673544(11)240625(17)260531(10)4177382
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K220212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: 05/31/2026
• Device Catalogue Number: 367354
• Device Lot Number: 4177382
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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