MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXTENSION SET MIC TUBING 60 INCH; INTRAVASCULAR ADMINISTRATION SET

Model Number	30914
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using extension set mic tubing 60 inch that there was a crack in the tubing and leakage occurred.The following information was provided by the initial reporter: the microbore extension set used had primed with ease.Placed the hizentra medication syringe into the iv alaris pump.After starting the medication to infuse, noticed immediately leakage from the medication syringe tip and microbore extension set.Removed medication from the iv alaris pump and asked another colleague to help me assess the syringe and tubing.We removed the hizentra medication syringe and assessed for any cracks in the tip of the syringe.We then assessed the tubing and placed a 5 ml ns syringe onto the tip of the microbore extension set and immediately saw a leak on the side of the insertion site tip of the tubing.There is a crack in the tubing.
Additional Manufacturer Narrative
H.6.Investigation summary: a complaint of a set having flow issues, and then cracking and leaking was received from the customer.A photo was provided by the customer.Through visual inspection, the customer complaint was confirmed.A crack can be seen in the female luer.Customer complaint of component damage was confirmed.Fluid blockage could not be confirmed without a sample.A device history record review for model 30914 lot number 21119833 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to a physical sample not being sent, a root cause for the damage could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported while using extension set mic tubing 60 inch that there was a crack in the tubing and leakage occurred.The following information was provided by the initial reporter: the microbore extension set used had primed with ease.Placed the hizentra medication syringe into the iv alaris pump.After starting the medication to infuse, noticed immediately leakage from the medication syringe tip and microbore extension set.Removed medication from the iv alaris pump and asked another colleague to help me assess the syringe and tubing.We removed the hizentra medication syringe and assessed for any cracks in the tip of the syringe.We then assessed the tubing and placed a 5 ml ns syringe onto the tip of the microbore extension set and immediately saw a leak on the side of the insertion site tip of the tubing.There is a crack in the tubing.

• Brand Name: EXTENSION SET MIC TUBING 60 INCH
• 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: 15034091
• Report Number: 9616066-2022-00907
• Device Sequence Number: 5248555
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/01/2022

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: 11/29/2024
• Device Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: 21119833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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