MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ BAG SPIKE, PRIMING VOLUME 0.5 ML; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2300E-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd smartsite¿ bag spike, priming volume 0.5 ml leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: device appears to be leaking after connector is applied.Multiple occurrences of leaking were noted.
Additional Manufacturer Narrative
H.6.Investigation summary: two photos of item no.2300e-0500 was received for quality investigation.The customer complaint of adapter/connector defective/damaged was confirmed by the photos the customer submitted.The photos indicate that the shape of the smartsites look to be in an oval shape and not a circle.If the oval shaped connector would be connected to a corresponding luer, there would be gaps in the connection that would allow for leakage.A device history record review for model 2300e-0500 lot number 22055346 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05may2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this complaint was determined to be a user error.Review of the assembly process and the verification process that the smartsites were constructed as designed, it was determined that user error would have been the reason that the connection would have leaked.A bd clinical team has been informed in order to determine if additional training is necessary at the user location.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported while using bd smartsite¿ bag spike, priming volume 0.5 ml leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: device appears to be leaking after connector is applied.Multiple occurrences of leaking were noted.

• Brand Name: BD SMARTSITE¿ BAG SPIKE, PRIMING VOLUME 0.5 ML
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15792700
• Report Number: 9616066-2022-01715
• Device Sequence Number: 11541537
• Product Code: FPA
• UDI-Device Identifier: 10885403235023
• UDI-Public: 10885403235023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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
• Operator of Device: Other
• Device Catalogue Number: 2300E-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown