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

Model Number	367290
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® luer adapter the device broken; needle separated from the luer adapter.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the luer adapter multi sample broke while administering to patient.".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: "bd received 10 samples and 1 photo for investigation.The photo shows the product packaging and lot number.Additionally, the customer samples were evaluated by cannula pull force testing and the indicated failure mode for cannula breaks off 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 cannula breaks off.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:  2023-05-26.
Event or Problem Description
It was reported when using the bd vacutainer® luer adapter the device broken; needle separated from the luer adapter.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the luer adapter multi sample broke while administering to patient.".

• Brand Name: BD VACUTAINER® 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17102928
• Report Number: 1024879-2023-00361
• Device Sequence Number: 12305165
• Product Code: JKA
• UDI-Device Identifier: 50382903672900
• UDI-Public: 50382903672900
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/16/2023

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: 11/30/2025
• Device Model Number: 367290
• Device Catalogue Number: 367290
• Device Lot Number: 2335720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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