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

Catalog Number	10014916
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ syringe module administration set had flow issues and would not let anything infuse beyond the disc during use.The following information was provided by the initial reporter: "this is not an equipment malfunction.It's for the supply malfunction.Syringe admin set would not let anything infuse beyond the disc that gets placed onto the pump.The disc would bubble up.".
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¿ syringe module administration set had flow issues and would not let anything infuse beyond the disc during use.The following information was provided by the initial reporter: "this is not an equipment malfunction.It's for the supply malfunction.Syringe admin set would not let anything infuse beyond the disc that gets placed onto the pump.The disc would bubble up.".
Additional Manufacturer Narrative
Investigation summary: one sample (model #10014916 ) was returned from the customer for investigation.It was reported by customer that "syringe admin set would not let anything infuse beyond the disc that gets placed onto the pump.The disc would bubble up".The set was examined for defects and abnormalities.No defects or abnormalities was observed.The set was attempted to be flushed with water using a bd 10ml syringe.The syringe admin set would not let anything infuse beyond the disc that placed onto the set.The disc would bubble up while flushing.For further testing tube was cut between the disc and the circular filter and water attempted to be flushed with water , this time water infused beyond the disk, and it was observed that occlusion was preventing the flow of fluid.The sample was examined for excessive solvent under magnification and excess solvent was observed.Quality notification was sent to supplier for further investigation with sample.A flow test was performed and an occlusion between the tubing and filter was observed.A device history record review for model 10014916 and lot number 22105551 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.Root cause: after investigation, the potential root cause for occlusion between the tubing and filter is related to an excess of solvent in the assembly and incorrect tubing handling method before to add solvent due to assembler error.

• Brand Name: BD ALARIS¿ SYRINGE MODULE ADMINISTRATION 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: 16358483
• Report Number: 9616066-2023-00188
• Device Sequence Number: 6432374
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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): 03/06/2023

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: 10/18/2025
• Device Catalogue Number: 10014916
• Device Lot Number: 22105551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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