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

Model Number	30204E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).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 tubing was cracked and leaked blood during use.The following information was provided by the initial reporter: "after pressing run procedure "no replacement fluid detected" alarmed and it was noted that blood was leaking from the draw line lines were clamped and it was found that the cause was the extension tubing was defective/cracked.".
Additional Manufacturer Narrative
Investigation summary: a complaint of tubing ballooning and leaking during infusion was received from the customer.A sample was received for investigation.The tubing was deformed and looked as if it had ballooned.No cracks or tears were observed on the tubing.The manufacturing plant was notified of this defect and an investigation was performed.A device history record review for model 30204e lot number 21039703 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this defect could not be linked to the manufacturing process.It was determined to be an isolated event possibly from shipping and handling.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set tubing was cracked and leaked blood during use.The following information was provided by the initial reporter: "after pressing run procedure "no replacement fluid detected" alarmed and it was noted that blood was leaking from the draw line lines were clamped and it was found that the cause was the extension tubing was defective/cracked.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12781794
• Report Number: 9616066-2021-52395
• Device Sequence Number: 3459494
• Product Code: FPA
• UDI-Device Identifier: 50885403235175
• UDI-Public: 50885403235175
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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 Expiration Date: 03/26/2024
• Device Model Number: 30204E
• Device Catalogue Number: 30204E
• Device Lot Number: 21039703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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 Age: 29 YR
• Patient Sex: Female