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

Catalog Number	20128E
Medical Device Problem Codes	Defective Component (2292); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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 extension set was damaged the following information was received by the initial reporter with the following verbatim: i am looking for alternatives to our current filter we use in our nicu.We use ref 20128e bd smartsite extension set but are having issues with them blowing.Customer reply: ¿ what is the date of event? this has occurred several times over the past year ¿ please share the lot number.Don¿t have those numbers at this time ¿ describe any patient harm, injury, complication or negative outcome that occurred because of the event.Negative outcome is that we have to replace the filter.Potential harm is air embolism if we did not replace the filter.
Event or Problem Description
Additional information received.Material#: 20128e, batch number#: unknown.It was reported by customer that they are looking for alternatives to our current filter they use in our nicu.They use ref 20128e bd smartsite extension set but are having issues with them blowing.Verbatim#: rcc received a complaint via email.Email(s) attached.I am looking for alternatives to our current filter we use in our nicu.We use ref 20128e bd smartsite extension set but are having issues with them blowing.Customer reply: for the purposes of clarification, i want to define the word being used to describe your events "blowing" as not breaking, cracking, leaking or specifically occlusions but rather your infusions backing up the line.This is important for our data and to be on the same page.What is the date of event? this has occurred several times over the past year.Please share the lot number.Don¿t have those numbers at this time.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.Negative outcome is that we have to replace the filter.Potential harm is air embolism if we did not replace the filter.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? in the past we have thrown them away but i have asked staff to please keep any filters moving forward.Please share the captured photo of the event if available.Don¿t have any at this time.
Additional Manufacturer Narrative
Date received by manufacturer updated.Short description correction.No product or photo was returned by the customer.The customer complaint of component damage - no leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 20128e because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been.

• 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: 18978172
• Report Number: 9616066-2024-00478
• Device Sequence Number: 6233643
• Product Code: FPA
• UDI-Device Identifier: 37613203011847
• UDI-Public: (01)37613203011847
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 03/29/2024

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: 20128E
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown