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

Catalog Number	20127E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 extension set was damaged the following information was received by the initial reporter with the following verbatim: customer states the tubing broke right above the filter.Product number: 20127e no serial number.Customer will return machine if needed.
Additional Manufacturer Narrative
It was reported that the tubing broke from the filter.One sample model 20127e was returned for investigation.The set was examined for defects and abnormalities.The filter outlet port was broken off from the filter.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the supplier investigation, investigation into the observed damage to the inlet housing port has been conducted, the automated manufacturing line has been reviewed for potential areas in which the inlet port may be contacted by the equipment with no such areas identified.A visual inspection has been conducted during the manufacture of this batch with no critical defects being reported.Furthermore, there are inline vision systems in place within our automated process to detect the presence of both the inlet and outlet ports during production.In conclusion, no instances within manufacturing have highlighted a manufacturing root cause.A device history record review for model 20127e, possible lot number 23129201 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28 jun 2022.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
No additional info.

• Brand Name: BD ALARIS SMARTSITE 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19412396
• Report Number: 9616066-2024-00802
• Device Sequence Number: 16947282
• Product Code: FPA
• UDI-Device Identifier: 07613203019248
• UDI-Public: (01)07613203019248
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 09/20/2024

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: 20127E
• Device Lot Number: UNKNOWN
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown