MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD INJECTOR LUER LOCK N35C MULTIPACK; INTRAVASCULAR ADMINISTRATION SET

Model Number 515005

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd injector luer lock n35c multipack there was needle exposure defective injector.The following information was provided by the initial reporter.The customer stated: "after the end of infusion of the (b)(6) given in an outpatient setting, the hcp attempted to switch to saline and the needle of the injector was exposed.".

Manufacturer Narrative

H6: investigation summary photos received for investigation, upon visual inspection, the injector was luer connected to a connector and the handles of the safety sleeve had been pulled out of place; most likely caused by user misuse of the device during connection/disconnection of the phaseal device against the mat component.A review of the device history could not be performed due to the unknown lot number.We were also unable to request retained samples in order to replicate the event.The product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specifications and there is no damage to the product.It is important to hold the white part of the injector before engaging/disengaging.Do not touch the blue part; if the handles of the safety sleeve are pulled out of place, the injector is activated causing exposure of the needle.The injector must be removed by pulling it backwards: if it is removed without doing this, the grips are pulled out of place causing exposure of the needle.If the injector has been forced when snapping it into place, the grips may also be damaged.Based on the quality team's investigation, we are unable to identify a root cause related to our manufacturing process at this time.It is important to follow the instructions for use when using phaseal devices to ensure that the product functions properly.

Event Description

It was reported when using the bd injector luer lock n35c multipack there was needle exposure - defective injector.The following information was provided by the initial reporter.The customer stated: "after the end of infusion of the anticancer agent (endoxan) given in an outpatient setting, the hcp attempted to switch to saline and the needle of the injector was exposed.".

• Brand Name: BD INJECTOR LUER LOCK N35C MULTIPACK
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: 12847228
• MDR Text Key: 285076656
• Report Number: 3003152976-2021-00769
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 50382905150055
• UDI-Public: 50382905150055
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123213
• 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: 12/30/2021

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
• Device Operator: Health Professional
• Device Model Number: 515005
• Device Catalogue Number: 515005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 12/30/2021
• Supplement Dates FDA Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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