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

Catalog Number	10010903
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris smartsite gravity blood set separated the following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.The bag spikes are separating from the tubing.
Additional Manufacturer Narrative
It was reported that the tubing separated from the bag spikes.One sample model 10010903, lot 24029351 was returned for investigation.The set was examined for defects and abnormalities.The tubings were separated from the bag spikes.No other defects or abnormalities were observed.Visual inspection under the microscope showed no signs of solvent on the tubing.The customer complaint was verified and a quality notification was sent to the manufacturer.A device history record review for model 10010903 lot number 24029351 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15feb2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.From the manufacturer's investigation, the potential root cause is due to the assembler using an incorrect solvent application method.A quality alert was created on june 10th, 2024 to communicate the failure and reinforce the correct solvent application method and correct use of the fixture to avoid the separation due to lack of solvent.
Event or Problem Description
No additional info.

• Brand Name: BD ALARIS SMARTSITE GRAVITY BLOOD 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19608275
• Report Number: 9616066-2024-00927
• Device Sequence Number: 6334486
• Product Code: FPA
• UDI-Device Identifier: 07613203020879
• UDI-Public: (01)07613203020879
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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 Catalogue Number: 10010903
• Device Lot Number: 24029351
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown