MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXTENSION SET MICROBORE SLIDE CLAMP 0.55 ML FLUID PATH STERILE; INTRAVASCULAR ADMINISTRATION SET

Model Number	30914
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd extension set microbore slide clamp 0.55 ml fluid path sterile the tubing was blocked.There was no report of patient impact.The following information was provided by the initial reporter: syringe line unable to flush any fluids or meds.No visible damage to line.No injury to patient.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd extension set microbore slide clamp 0.55 ml fluid path sterile the tubing was blocked.There was no report of patient impact.The following information was provided by the initial reporter: syringe line unable to flush any fluids or meds.No visible damage to line.No injury to patient.
Additional Manufacturer Narrative
H6: investigation summary one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.Excess solvent was observed by the female luer.A quality notification was sent to the manufacturer.From the manufacturer investigation the root causes are a lack of set air sweep time and a lack of rest time.Corrective actions were implemented with activities started on may 12,2022 and completed on july 12, 2022.A device history record review for model 30914 lot number 21109145 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22oct2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD EXTENSION SET MICROBORE SLIDE CLAMP 0.55 ML FLUID PATH STERILE
• 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: 14160222
• Report Number: 9616066-2022-00433
• Device Sequence Number: 2945506
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 09/22/2022

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: 10/14/2024
• Device Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: 21109145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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