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

Model Number	20041E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a 20041e product was not available for investigation, however the customer provided a photograph of affected sample; analysis of the photograph confirmed the customer's experience with the female luer observed to be cracked.Further information provided by the customer indicates that the component had not been disinfected prior to connection.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21035183 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Previous investigations have confirmed that complaints of this nature can be caused or contributed by a combination of different factors, including over-torque of the component during connection with the male luer, use of a male luer that is not compliant to iso standards, or prolonged use of substances that are aggressive to plastics.In this instance the connecting product in use at the time of the customer's experience was not available for investigation and therefore it has not been possible to confirm if this may have contributed to the customer's experience.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 this is a rare occurrence with a small number of similar reports against the 20041e set in the past 12 months.
Event or Problem Description
It was reported when using the bd smartsite¿ extension sets the tubing was defective/damaged.The following information was provided by the initial reporter.The customer stated: the tube was broken.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-11-09.H6: investigation summary one 20041e sample was received without packaging for investigation, however the customer indicated that the complaint sample was from lot 21035183.No connecting products were received to assist the investigation.A visual inspection confirmed the customer's experience with the female luer observed to be cracked leakage was observed from the crack during a flush through of the set.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21035183 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Previous investigations have confirmed that complaints of this nature can be caused or contributed by a combination of different factors, including over-torque of the component during connection with the male luer, use of a male luer that is not compliant to iso standards, or prolonged use of substances that are aggressive to plastics.In this instance based on the information available it has not been possible to confirm which of these factors may have contributed to the customer's experience.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 20041e set in the past 12 months.
Event or Problem Description
It was reported when using the bd smartsite¿ extension sets the tubing was defective/damaged.The following information was provided by the initial reporter.The customer stated: the tube was broken.".

• Brand Name: BD SMARTSITE¿ EXTENSION SETS
• 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: 12781239
• Report Number: 9616066-2021-52393
• Device Sequence Number: 5749579
• Product Code: FPA
• UDI-Device Identifier: 27613203021665
• UDI-Public: 27613203021665
• 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): 11/12/2021

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: 03/10/2024
• Device Model Number: 20041E
• Device Catalogue Number: 20041E
• Device Lot Number: 21035183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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