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

Model Number	10108964
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 distal end of the bd alaris¿ smartsite¿ extension set leaked when priming the tubing.This occurred with 2 sets during use.The following information was provided by the initial reporter: "the very distal end leaks after the tubing is primed".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 distal end of the bd alaris¿ smartsite¿ extension set leaked when priming the tubing.This occurred with 2 sets during use.The following information was provided by the initial reporter: "the very distal end leaks after the tubing is primed".
Additional Manufacturer Narrative
H6: investigation summary one sample was submitted for quality evaluation.The customer complaint of leakage could not be verified by investigation and testing.The submitted sample was first visually inspected for any damages to the assembly components.There were no issues found during the visual inspection.The extension set was then primed and examined for leakage, air-in-line and occlusion.No issues were found during the priming of the extension set.The extension set was then attached to a primary infusion set and a simulated infusion was conducted at a rate of 200 ml/hr.There was no leakage, air-in-line or occlusions found during testing.No other issues were found during the evaluation of the extension set.A device history record review for model 10108964 lot number 21099001 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 01sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be established because the reported failure could not be replicated during testing of the submitted sample.
Event or Problem Description
It was reported that the distal end of the bd alaris¿ smartsite¿ extension set leaked when priming the tubing.This occurred with 2 sets during use.The following information was provided by the initial reporter: "the very distal end leaks after the tubing is primed".

• 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: 13170437
• Report Number: 9616066-2021-52672
• Device Sequence Number: 1765108
• Product Code: FPA
• UDI-Device Identifier: 50885403234147
• UDI-Public: 50885403234147
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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 Model Number: 10108964
• Device Catalogue Number: 10108964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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