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

Catalog Number 515008

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 that the notch of the bd phaseal¿ injector luer lock n35j was broken while connecting it with the vial of endoxan during use, exposing the needle.The following information was provided by the initial reporter, translated from (b)(6) to english: "connected with injector and the vial of endoxan.The notch of the injector had been broken and the spike needle became exposed.".

Event Description

It was reported that the notch of the bd phaseal¿ injector luer lock n35j was broken while connecting it with the vial of endoxan during use, exposing the needle.The following information was provided by the initial reporter, translated from japanese to english: "connected with injector and the vial of endoxan.The notch of the injector had been broken and the spike needle became exposed.".

Manufacturer Narrative

H.6.Investigation: one sample was returned to our quality team for investigation.Upon inspecting the product, the notches on the tip of the injector were broken and the injector was noted to not be fully connected to the protector properly.Manufacturing personnel conduct a series of testing and inspections to ensure the quality and functionality of the device.As lot information for this incident was not available, a device history review could not be performed and additional retained samples could not be evaluated.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.It is important to hold onto the white components of the injector when engaging/disengaging; and not grip the blue safety sleeve.It was determined this incident likely occurred as a result of improperly disengaging the device.

• 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: 8870678
• MDR Text Key: 153889446
• Report Number: 3003152976-2019-00505
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515008
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other