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

Catalog Number	20041E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: two 20041e samples were received without packaging, however the lot number was indicated as 21085733.A connecting 10ml angel flush syringe was also received to assist the investigation.Functional testing involved flushing fluid through the received products using the 10ml angel flush syringe; no occlusions or flow restrictions were observed during testing of the returned samples, and the piston of the smartsite opened upon connection to the syringe for all samples tested.A raised ridge was visible around edge of the tip of the male luer of the returned angel syringe, such features have shown to contribute to smartsite incompatibility during previous investigations.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21085733 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.However previous similar reports for occlusions have been related to features on the surface of the male luer of the connecting products.These features include flash or a raised edge to the tip of the male luer which have previously been shown to intermittently lead to restricted flow due to them pinching the blue piston of the smartsite® and not allowing it to open.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.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 device experienced an occlusion.This event occurred two times.The following information was provided by the initial reporter.The customer stated: connector occlusion.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13048337
• Report Number: 9616066-2021-52623
• Device Sequence Number: 14431445
• Product Code: FPA
• UDI-Device Identifier: 07613203011914
• UDI-Public: 07613203011914
• 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
• Report Date (Section B): 11/30/2021

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: 08/24/2024
• Device Catalogue Number: 20041E
• Device Lot Number: 21085733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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