MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL INJECTOR LURE LOCK N35; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515008

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 09/03/2023

Event Type  malfunction  

Manufacturer Narrative

D.4 device expiration date: unknown.E.1 initial reporter phone #: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the bd phaseal injector lure lock n35 needle exposed while disengagement.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the needle of the product came out.Damage (needle came out) occurred when attaching and detaching the spike set and product.Confirmation was requested as to whether this was a product defect or an operational issue.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 28-sep-2023.H.6.Investigation summary: both photos and the physical sample were provided to our quality team for investigation.Through visual inspection of the sample, the claws of the safety sleeve are bent, and the injector needle was exposed.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 number involved in this incident is unknown, a device history review cannot be performed.It is important to grip the white injector components when engaging/ disengaging; do not grip the blue safety sleeve.If the safety sleeve grips become dislocated, the injector is activated causing needle exposure.To prevent damage to the handles of the safety sleeve, the injector must be removed by pulling it backwards and must not be forcefully engaged.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, not properly pressing the injector down before rotating to engage the injector with the mating device.The instructions for use must be carefully followed when using phaseal devices in order to avoid any damage to the product that may result in the device not functioning as intended.

Event Description

It was reported that the bd phaseal injector lure lock n35 needle exposed while disengagement.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the needle of the product came out.Damage (needle came out) occurred when attaching and detaching the spike set and product.Confirmation was requested as to whether this was a product defect or an operational issue.

• Brand Name: BD PHASEAL INJECTOR LURE LOCK N35
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17789876
• MDR Text Key: 323944025
• Report Number: 3003152976-2023-00404
• Device Sequence Number: 1
• Product Code: FPA
• 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: 10/22/2023

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
• Device Operator: Other
• Device Catalogue Number: 515008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 10/22/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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