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

Model Number	30914
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2022
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 would not flush fluid through the tubing.The following information was provided by the initial reporter: unable to flush any fluid through tubing.
Event or Problem Description
It was reported that the bd alaris¿ extension set would not flush fluid through the tubing.The following information was provided by the initial reporter: unable to flush any fluid through tubing.
Additional Manufacturer Narrative
H.6.Investigation summary: one sample (model #30914) was returned for investigation.It was reported that they are unable to flush any fluid through the tubing.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Fluid was attempted to be flushed through the line.The set was unable to be flushed at all, with an occlusion seeming to be at the top connector of the tubing.The customer complaint can be verified.The set was further examined under magnification where an occlusion can be observed.A quality notification has been sent to the manufacturer, and the sample has been sent for further investigation.The manufacturer was able to confirm the failure.A mapping of the manufacturing process was carried out.According to the investigation performed, the principal root causes are: 1.Lack of set air sweep time in operation 2.It was detected during the assembly of the set that the air sweep time was not enough, which indicates that the set should be left in the air hose or fixture until the new assembly is carried out, ensuring the time of air sweeping.2.Lack of rest time.It is indicated that a kanban of 50 pieces must be made before testing the flow meter.However, it is necessary to ensure that the first piece in is the first piece out, to have the longest resting time.A device history record review for model 30914 lot number 22049017 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 06apr2022.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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15140794
• Report Number: 9616066-2022-01036
• Device Sequence Number: 7267835
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 04/04/2025
• Device Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: 22049017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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