MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL INJECTOR LUER LOCK N35J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515008

Device Problem Retraction Problem (1536)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 bd phaseal" injector luer lock n35j had a separation of the injector and mating component which led to needle exposure.The following information was provided by the initial reporter: "this is a report about an exposed injector needle possibly due to a broken safety sleeve.".

Event Description

It was reported that bd phaseal¿ injector luer lock n35j had a separation of the injector and mating component which led to needle exposure.The following information was provided by the initial reporter: "this is a report about an exposed injector needle possibly due to a broken safety sleeve.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-23.H6: investigation summary.One injector was provided to our quality team for investigation.Through visual inspection, the injector membrane was noted to have been penetrated multiple times, the injector was not properly connected on to the mating device, the needle is observed to be exposed, and the injector grips are moved from their original place.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.As the lot involved in this incident is unknown, a device history review cannot be performed.It is important to hold onto the white components of the injector when engaging/disengaging; do not grip the blue safety sleeve.If the grips of the safety sleeve become dislocated, the injector is activated causing needle exposure.To avoid damage to the safety sleeve grips, the injector must be removed by pulling it straight back and it cannot be forcefully engaged.The instructions for use must be carefully followed when using the phaseal devices in order to avoid any damage to the product that may result in the device not functioning as intended.Based on the investigation and sample evaluation, it was determined this incident is related to improper engagement/disengagement of the device.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PHASEAL INJECTOR LUER LOCK N35J
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12230244
• MDR Text Key: 264127114
• Report Number: 3003152976-2021-00421
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1