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

Model Number 515003

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd phaseal¿ injector luer lock n35 leaked during use.The following information was provided by the initial reporter: there is a leakage at the bottom of the injector device through the opening.

Event Description

It was reported that bd phaseal¿ injector luer lock n35 leaked during use.The following information was provided by the initial reporter: there is a leakage at the bottom of the injector device through the opening.

Manufacturer Narrative

H6.Investigation: one photo was provided to our quality tram for investigation.Upon inspection of the photo, the location of the leak is indicated, however, there is no visible evidence a leak occurred.A device history was performed and found no no-conformances related to the reported issue during production of batch 2002115.Three retained samples of the same lot were used for additional evaluation.The product was evaluated and no damage or defects were observed.Functional testing was performed on the sample using a protector and syringe.Each sample was tested ten times and no leakages were observed.Product undergoes visual and functional testing through manufacturing, ensuring all critical dimension are within specification.Results were reviewed for the reported lot and no issues related to the reported incident were identified.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.H3 other text : see h10.

• Brand Name: BD PHASEAL INJECTOR LUER LOCK N35
• 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: 10228599
• MDR Text Key: 198736708
• Report Number: 3003152976-2020-00285
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905150037
• UDI-Public: 30382905150037
• Combination Product (y/n): N
• PMA/PMN Number: K140591
• 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: 07/24/2020

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 Expiration Date: 07/31/2022
• Device Model Number: 515003
• Device Catalogue Number: 515003
• Device Lot Number: 2002115
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other