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

Model Number	515004
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9873836
• Report Number: 3003152976-2020-00141
• Device Sequence Number: 13616763
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other