MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366408
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® no additive (z) plus tubes, the stopper pops off of 20 tubes.No patient impact reported.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6.Investigation summary: bd did not receive samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode of stopper creepout/pop off was not observed.  additionally, 29 retention samples from bd inventory were evaluated by functional testing.Samples were subjected to a 1st and 2nd stopper pullout test.None of the 29 samples resulted in 2nd stopper creepout/pop off.Device history record review of reported incident lot determined all product release requirements were met, and there were no related quality issues during product manufacture.This complaint was unable to be confirmed for indicated failure mode of stopper creepout/pop off.Bd was unable to identify a root cause for 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.H3 other text : see h10.
Event or Problem Description
It was reported that while using bd vacutainer® no additive (z) plus tubes, the stopper pops off of 20 tubes.No patient impact reported.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18232451
• Report Number: 1024879-2023-00856
• Device Sequence Number: 7152835
• Product Code: FMH
• UDI-Device Identifier: 50382903664080
• UDI-Public: (01)50382903664080
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• 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): 12/19/2023

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: 09/30/2024
• Device Catalogue Number: 366408
• Device Lot Number: 3108162
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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