MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL INJECTOR LUER LOCK N35C; INTRAVASCULAR ADMINISTRATION SET

Model Number 515004

Device Problem Packaging Problem (3007)

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

Event Date 03/03/2020

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 the cap on the bd phaseal injector luer lock n35c was missing before use.The following information was provided by the initial reporter: "cap on the injector was missing.".

Manufacturer Narrative

H.6.Investigation: no photos or physical samples that display the reported issue were provided for investigation.As the lot involved in this incident is unknown, a device history review could not be performed.Product undergoes visual and functional testing throughout manufacturing according to procedure.Based on the available information we are not able to identify a root cause at this time.

Event Description

It was reported that the cap on the bd phaseal¿ injector luer lock n35c was missing before use.The following information was provided by the initial reporter: "cap on the injector was missing.".

• Brand Name: BD PHASEAL INJECTOR LUER LOCK N35C
• 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: 9873836
• MDR Text Key: 202539505
• Report Number: 3003152976-2020-00141
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• 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: 04/14/2020

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 Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other