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	Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: lot was reported; however, this is not a lot # h37030207e19 manufactured for the reported catalog #.Device expiration date: unknown.Device manufacture date: unknown.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 unable to prime.The following information was provided by the initial reporter: dual port extension port was unable to prime due to anti-reflux valve not working.
Event or Problem Description
It was reported that the bd alaris smartsite dual-port extension set was unable to prime.The following information was provided by the initial reporter: dual port extension port was unable to prime due to anti-reflux valve not working.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 22039018.D4: medical device expiration date: 03-mar-2025.H4: device manufacture date: 03-mar-2022.D10: device available for eval yes.D10: returned to manufacturer on: 17-nov-2022.H6: investigation summary one 30207e sample from lot 22039018 was received in opened packaging for investigation; residual fluid was present in the device.The feedback provided by the customer suggests a complete occlusion was detected at the back check valve (bcv) during attempts to prime the infusion set.Functional testing was performed by connecting the returned sample to a 50ml bd plastipak syringe from stock and attempting to flush with fluid; a complete occlusion was detected at the bcv, confirming the customer's experience.No occlusions or flow restrictions were detected from the line without the back check valve.The bcv was then disassembled from the infusion set and a close inspection of the component performed; some excess material was identified at the inlet port of the bcv component.The details of this feedback were forwarded to the manufacturing site as well as to the supplier of the bcv component for investigation.They confirmed that during injection moulding of the bcv an excess of material is likely to have formed within the lumen of the inlet port, which resulted in an occlusion of the component.A definitive root cause for this excess material was not identified during the investigation, however a supplier corrective action request has been raised in order for the supplier to further investigate the root cause of this defect.A review of the production records for lot 22039018 did not identify any in-process testing failures or quality deviations which may have caused or contributed to reports of this nature.

• 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 ; 8015296192
• MDR Report Key: 15893786
• Report Number: 9616066-2022-01817
• Device Sequence Number: 6698496
• Product Code: FPA
• UDI-Device Identifier: 07613203011495
• UDI-Public: 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 03/03/2025
• Device Catalogue Number: 30207E
• Device Lot Number: 22039018
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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