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

Catalog Number	30207E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 30207e sample was received in opened packaging from lot 24029397 for investigation.A small amount of clear residual was present in the tubing and the dust caps were in place.The customer reported that several sets from the same lot were blocked and they were unable to flush.The returned sample was subjected to functional testing by priming and subjecting to an infusion using a 50ml bd plastipak syringe and it was found that the fluid was able to pass until it was at the back check valve (bcv).After several attempts, the flow resumed and no occlusion or restriction of flow was observed again.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as although a flow restriction was initially present, no solvent was visible at the affected tubing joint which may have contributed.It was not possible to determine whether the customer's experience was as a result of infused fluid that had partially solidified or as a result of a temporary occlusion of the bcv.A review of the production records for lot 24029397 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.
Event or Problem Description
It was reported that bd alaris smartsite dual-port extension set was occluded the following information was received by the initial reporter with the following verbatim: no fluid running when connected to extension set.Tested with syringe and found to be blocked.Several from the same batch were found to be blocked.

• Brand Name: BD ALARIS SMARTSITE DUAL-PORT 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: 19583796
• Report Number: 9616066-2024-00912
• Device Sequence Number: 19691516
• Product Code: FPA
• UDI-Device Identifier: 07613203011495
• UDI-Public: (01)07613203011495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2024

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: 30207E
• Device Lot Number: 24029397
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown