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

Catalog Number	25202E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 extension set leaked near the hub.The following information was provided by the client: "extension set leaking - "we have been seeing some iv set leakage it seems it¿s a the point where the tubing is going into the hub.It is item 25202e this lot number is (10) 21129276.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval: yes.D.10.Returned to manufacturer on: 25-mar-2022.H.6.Investigation summary: the customer reported there is leakage, and returned 7 samples of material 25202e.Five of the seven samples leaked and separated at the entrance of the male luer.Inspection under the microscope found the samples to have insufficient solvent.Manufacturing performed a further investigation and found several potential root causes for the failure.A quality notification was created to prevent the defect.A device history record review for model 25202e lot number 21129276 was performed.The search showed that a total of 21,003 units in 1 lot number was built on 06dec2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd alaris smartsite extension set leaked near the hub.The following information was provided by the client: "extension set leaking- "we have been seeingsome iv set leakage it seems it¿s a the point where the tubing is going into the hub.It is item 25202e this lot number is (10) 21129276."".

• Brand Name: BD ALARIS SMARTSITE 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: 13980544
• Report Number: 9616066-2022-00340
• Device Sequence Number: 20325565
• Product Code: FPA
• UDI-Device Identifier: 50885403235144
• UDI-Public: 0150885403235144
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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 Expiration Date: 12/02/2024
• Device Catalogue Number: 25202E
• Device Lot Number: 21129276
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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