MAUDE Adverse Event Report: BECTON DICKINSON, S.A. INJECTOR LUER LOCK N35J

Catalog Number 515008

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that injector luer lock n35j was disengaged with the needle exposed.The following information was provided by the initial reporter: the customer reported that the injector was disengaged with the needle exposed.The drug used is an anticancer agent with the name unknown.

Event Description

It was reported that injector luer lock n35j was disengaged with the needle exposed.The following information was provided by the initial reporter: the customer reported that the injector was disengaged with the needle exposed.The drug used is an anticancer agent with the name unknown.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-08.H6: investigation summary one sample was submitted to our quality team for investigation.Through visual inspection, it is noted that the injector needle is exposed and the injector handles are displaced from their original location.The product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification.The dhr of lot 2009007 involved is reviewed without finding any deviations or non-conformance to the reported defect.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.It appears that this incident was due to excessive force during connection/disconnection of the device.

• Brand Name: INJECTOR LUER LOCK N35J
• Type of Device: INJECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12496991
• MDR Text Key: 272204390
• Report Number: 3003152976-2021-00607
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 515008
• Device Lot Number: 2009007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1