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

Model Number	20029E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ extension set experienced leakage.The following information was provided by the initial reporter: iv med line tubing and med line extension set with filter leaking at site of connection from tubing to filter extension set.
Event or Problem Description
It was reported that the bd alaris¿ extension set experienced leakage.The following information was provided by the initial reporter: iv med line tubing and med line extension set with filter leaking at site of connection from tubing to filter extension set.
Additional Manufacturer Narrative
Investigation summary: the customer reported connection issues with two sets, and returned one used each of material#: 20029e and material#: 10014914.The two sets were connected in both orientations and was flushed with the returned 10 ml syringe.No leak was observed at the connection of the sets.However, a leak was observed at the filter, and the complaint of leakage is verified.The root cause for the leakage in filter is air vent membrane was wetted out.The filter was attempted to be flushed with ipa/water but the filter was occluded.The root cause for the filter leak is unknown.Filters are known to leak when used with certain drugs, reach out to customer advocacy for more information.A device history record review for model: 20029e lot number: 21016605 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27jan2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model: 10014914 lot number: 21075859 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23jul2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS¿ 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: 12684907
• Report Number: 9616066-2021-52296
• Device Sequence Number: 4238418
• Product Code: FPA
• UDI-Device Identifier: 50885403234864
• UDI-Public: 50885403234864
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/04/2021

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: 01/27/2024
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Device Lot Number: 21016605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AS SYR PSD MICROBORE.
• Patient Sex: Unknown