MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367290
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H4.Device manufacture date: unknown.
Event or Problem Description
It was reported that while using bd vacutainer® multiple sample luer adapter, when disconnecting from the iv connection tubing, the hub separated from the device.One (1) device was affected.No patient impact reported.
Additional Manufacturer Narrative
H.6 investigation summary material #: 367290 lot/batch #: unknown bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for cannula hub breaks off was observed.Bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint has been confirmed for the indicated failure mode cannula hub breaks off.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.
Event or Problem Description
It was reported that while using bd vacutainer® multiple sample luer adapter, when disconnecting from the iv connection tubing, the hub separated from the device.One (1) device was affected.No patient impact reported.

• Brand Name: BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
• 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: 19025805
• Report Number: 1024879-2024-00307
• Device Sequence Number: 15259798
• Product Code: JKA
• UDI-Device Identifier: 50382903672900
• UDI-Public: (01)50382903672900
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K991088
• 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): 04/04/2024

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 Catalogue Number: 367290
• Device Lot Number: UNKNOWN
• 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: 03/09/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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