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

Model Number	20028E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd smartsite¿ extension set was clogged.The following information was provided by the initial reporter: it was reported by the customer that they can not flush through the extension set.
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that the bd smartsite¿ extension set was clogged.The following information was provided by the initial reporter: it was reported by the customer that they can not flush through the extension set.
Additional Manufacturer Narrative
H6: investigation summary: 2 samples were returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sets were attached to a bd primary set primed with 85% glycerin / 15% water solution and allowed to prime using gravity.The sets were unable to be primed using gravity.A quality notification was sent to the supplier.During the supplier investigation excess solvent was observed.A quality notification was sent to the manufacturer.The manufacturer investigation found the main root cause to be attributed to double gumming (repeated application of solvent).As a preventative action a quality notification was created for this defect.A device history record review for model 20128e lot number 21129190 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09dec2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h.10.

• Brand Name: BD 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14802149
• Report Number: 9616066-2022-00761
• Device Sequence Number: 14663662
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: 07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 11/25/2024
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• Device Lot Number: 21119585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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