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

Model Number	20051E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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¿ smartsite¿ extension set tubing leaked.The following information was provided by the initial reporter: "tube leak.".
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set tubing leaked.The following information was provided by the initial reporter: "tube leak".
Additional Manufacturer Narrative
H6: investigation summary a 20051e product was not available for investigation; however the customer confirmed that the complaint sample was from lot 21026589.As part of the investigation, the customer provided a photograph of the affected sample; analysis of the photograph identified that the tubing had been cut in two and appeared flattened at the cut region.The details of this feedback were forwarded to the manufacturing site for investigation.Previous investigations into complaints of this nature have identified that this type of damage is consistent with that caused when the tubing is caught in the heat seal of the packaging machine.If the set is not coiled in the packaging nest correctly, the seal around the edge of the packaging can be compromised by the tubing protruding out of the packaging.The tubing would then be caught in the packaging heat seal, causing the damaged and flattened appearance of the tubing.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lot 21026589 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against products manufactured at this manufacturing site.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12533657
• Report Number: 9616066-2021-52130
• Device Sequence Number: 1415424
• Product Code: FPA
• UDI-Device Identifier: 27613203021696
• UDI-Public: 27613203021696
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 02/27/2024
• Device Model Number: 20051E
• Device Catalogue Number: 20051E
• Device Lot Number: 21026589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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