MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL¿ INJECTOR LUER LOCK (N35C); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515005

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

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

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd phaseal¿ injector luer lock (n35c) was damaged and the needle was exposed.No serious injury or medical intervention was reported.

Event Description

It was reported that bd phaseal¿ injector luer lock (n35c) was damaged and the needle was exposed.No serious injury or medical intervention was reported.

Manufacturer Narrative

H.6.Investigation: one physical sample was evaluated by our quality team.Visual inspection revealed the needle was exposed and tip was damaged.The injector was found to be functional and was able to be connected to the connector.A device history review could not be performed as no lot information was provided.Injector needles become exposed if they are not properly disengaged, which also results in safety sleeve breakage.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.It has been determined that this incident most likely occurred due to improper use.The instructions for use must be carefully followed when using the phaseal devices.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK (N35C)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8360132
• MDR Text Key: 139096941
• Report Number: 2243072-2019-00301
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 50382905150055
• UDI-Public: 50382905150055
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other