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

Catalog Number 515003

Device Problem Device Slipped (1584)

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

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd phaseal¿ injector luer lock n35 there was an issue with needle through membrane.There was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd phaseal injector luer lock n35 there was an issue with needle through membrane.There was no report of injury or further medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.As a lot number was not provided for this incident, a production history record review could not be completed and retained samples could not be investigated.Since no picture samples or physical samples were available, a thorough sample investigation could not be completed.Needle exposure occurs when the safety sleeve is damaged.Safety sleeve breakage occurs when the injector is not properly engaged/disengaged.It is important to hold onto the white components of the injector when engaging and/or disengaging the device; and not touch the blue safety sleeve.If the grips of the safety sleeve are dislocated, the injector is activated and the needle is exposed.When disengaging the injector, the device must be removed by pulling straight back to avoid grip damage.If the injector has been forced while engaging, the grips may also become damaged.It is important to follow the instructions for use carefully when using the phaseal injector product.As it is explained the breakage occurs when the injector is not properly disengaged.User error.

• 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: 7786464
• MDR Text Key: 117436907
• Report Number: 3003152976-2018-00360
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515003
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other