MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE DUAL-PORT EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30207E
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris smartsite dual-port extension set was missing components.The following information was provided by the initial reporter: product missing components.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 13-feb-2023.H6: investigation summary : one 30207e sample from lot 22069295 was received in opened packaging for investigation; no residual fluid was detected in the device.As part of the investigation, the customer provided a photograph of the affected sample; analysis of the photograph in addition to a visual inspection of the returned sample confirms the customer's experience, as the female luer was missing from the set.Furthermore, a close inspection of the tubing did not identify any obvious signs of residual solvent.The details of this feedback were forwarded to the manufacturing site for further investigation.The missing female luer is likely to have been caused by human error during the hand assembly process; in this instance it is likely that the manufacturing operative inadvertently missed the assembly step where the female luer component is placed onto the tubing.
Event or Problem Description
It was reported that the bd alaris smartsite dual-port extension set was missing components.The following information was provided by the initial reporter: product missing components.

• Brand Name: BD ALARIS SMARTSITE DUAL-PORT EXTENSION SET
• 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 ; 8448235433
• MDR Report Key: 16433440
• Report Number: 9616066-2023-00261
• Device Sequence Number: 16943602
• Product Code: FPA
• UDI-Device Identifier: 07613203011495
• UDI-Public: (01)07613203011495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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 Expiration Date: 06/14/2025
• Device Catalogue Number: 30207E
• Device Lot Number: 22069295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• 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