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

Catalog Number	30262E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.Initial reporter e-mail: 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¿ extension set leaked blood from the tubing during use.The following information was provided by the initial reporter: "rn placed extension tubing on iv line, properly primed and reconnected to patient.Approximately 10 minutes later the patient called rn back to room.The entire extension tube was full of blood and was leaking near the connection to the iv tubing.After attempting to flush the line it was discovered that the extension line was leaking from the tubing not a poor connection.Rn replaced the extension tubing with new and restarted the iv.".
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set leaked blood from the tubing during use.The following information was provided by the initial reporter: "rn placed extension tubing on iv line, properly primed and reconnected to patient.Approximately 10 minutes later the patient called rn back to room.The entire extension tube was full of blood and was leaking near the connection to the iv tubing.After attempting to flush the line it was discovered that the extension line was leaking from the tubing not a poor connection.Rn replaced the extension tubing with new and restarted the iv.".
Additional Manufacturer Narrative
H6: investigation summary no photo or sample was received for the customer's complaint of leakage.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review for model 30262e lot number 22059381 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27may2022.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.

• 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: 15660195
• Report Number: 9616066-2022-01595
• Device Sequence Number: 17612990
• Product Code: FPA
• UDI-Device Identifier: 07613203011471
• UDI-Public: (01)07613203011471
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/12/2022

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: Health Professional
• Device Expiration Date: 05/27/2025
• Device Catalogue Number: 30262E
• Device Lot Number: 22059381
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 11/12/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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