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

Catalog Number	42103E-07
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that 12 bd alaris¿ smartsite¿ gravity sets pulled apart when removing them from the packaging.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "i do not feel confident this product will work for our system.After testing the case of 100 sets ¿ 14 were not clinically acceptable.12 sets ¿ pulled apart when right out of the package 1 set- kinked and likely not usable 1 set- package was opened and not sealed (not sure if that was done by xxxx prior to me getting the lot)".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 22129213.D4: medical device expiration date: 13-dec-2025.H4: device manufacture date: 12-dec-2022.D10: returned to manufacturer on: 08-aug-2023.H6: investigation summary: the customer reported multiple sets breaking out of the bag before use, and returned a large box of samples.There were 98 samples of the same lot number 22129213, and 43 of them had a separation at the drip chamber.The complaint is verified.The root cause for the separations is the solvent application process, and the plant is aware.There is a project to address the issue and fix the solvent dispenser equipment.Device history record review for model 42103e-07 lot number 22129213 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that 12 bd alaris¿ smartsite¿ gravity sets pulled apart when removing them from the packaging.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "i do not feel confident this product will work for our system.After testing the case of 100 sets ¿ 14 were not clinically acceptable.12 sets ¿ pulled apart when right out of the package.1 set- kinked and likely not usable.1 set- package was opened and not sealed (not sure if that was done by xxxx prior to me getting the lot)".

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17480898
• Report Number: 9616066-2023-01676
• Device Sequence Number: 18386456
• Product Code: FPA
• UDI-Device Identifier: 10885403225840
• UDI-Public: 10885403225840
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 09/28/2023

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: 12/13/2025
• Device Catalogue Number: 42103E-07
• Device Lot Number: 22129213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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