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

Catalog Number 515008

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Date 04/05/2019

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 that after the bd phaseal¿ injector luer lock n35j was connected to the c100j and primed, they wouldn't disengage.The following information was provided by the initial reporter, translated from (b)(6) to english: "engaged c100j with n35j and conducted priming in customized route , they didn't disengage.The needle was exposed when hcp tried to disengage them.".

Manufacturer Narrative

H.6.Investigation: one sample was returned to our quality team for investigation.Upon inspecting the product, the safety sleeve was observed to be broken, however, the injector could be properly attached to the infusion adapter and was functional.A device history review could not be performed as no lot information was provided for this incident.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.Manufacturing personnel conduct a series of testing and inspections throughout the manufacturing process to ensure quality and functionality of the product.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.The breakage of the grips usually happens when the injector is not properly handled.If the tips of the safety sleeve are removed from their place, the injector is activated causing needle exposure (as shows picture in jfrl report).It is recommended to carefully follow the instructions explained in the ifu.If injector is properly engaged, it can be properly disengaged.It does not seem likely that the injector arrived damaged.No issues are describe before the connection.

Event Description

It was reported that after the bd phaseal¿ injector luer lock n35j was connected to the c100j and primed, they wouldn't disengage.The following information was provided by the initial reporter, translated from japanese to english: "engaged c100j with n35j and conducted priming in customized route , they didn't disengage.The needle was exposed when hcp tried to disengage them.".

• 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: 8539709
• MDR Text Key: 144451959
• Report Number: 3003152976-2019-00283
• 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: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515008
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other