MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MICRO EXT SET W/1 SS VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010983
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
It was reported that micro ext set w/1 ss vlv tubing had air in the line.The following information was provided by the initial reporter: material no.: 10010983, lot no.: 20055744.It was reported that there was an occlusion withhin the tubing sets.Verbatim: i was trying to draw blood from my pt's picc line.It flushed well.I was able to draw up my waste without difficulty.But then it started drawing up air into my 3ml syringe.It filled the entire t-piece with air.I did not want to flush the air into my patient so i left everything as it was and paged iv therapy to come assess the line immediately.When iv therapy nurse took down the dressing, there was no visible crack, hole or loose connection.The blue part of the picc line (catheter) is filled with blood all the way up to the hub.She discarded the old t-piece and replaced with a new one that was flushed with saline.However, the line now would not flush or draw so she had to tpa the line.
Event or Problem Description
It was reported that micro ext set w/1 ss vlv tubing had air in the line.The following information was provided by the initial reporter: material no.: 10010983 lot no.: 20055744.It was reported that there was an occlusion within the tubing sets.Verbatim: i was trying to draw blood from my pt's picc line.It flushed well.I was able to draw up my waste without difficulty.But then it started drawing up air into my 3ml syringe.It filled the entire t-piece with air.I did not want to flush the air into my patient so i left everything as it was and paged iv therapy to come assess the line immediately.When iv therapy nurse took down the dressing, there was no visible crack, hole or loose connection.The blue part of the picc line (catheter) is filled with blood all the way up to the hub.She discarded the old t-piece and replaced with a new one that was flushed with saline.However, the line now would not flush or draw so she had to tpa the line.
Additional Manufacturer Narrative
H.6.Investigation: one sample was returned by the customer.It was reported that there was an occlusion within the tubing sets.The returned y-site was examined for defects and abnormalities.No defects and abnormalities were observed.The y-site was connected to a 10 ml syringe and flushed with 5 ml of water.The y-site was flushed normally.The failure was unable to be replicated.A device history record review for model #10010983 lot #20055744 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause was unable to be determined because the failure was unable to be replicated.

• Brand Name: MICRO EXT SET W/1 SS VLV
• 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 22244 ; MX 22244
• MDR Report Key: 10694546
• Report Number: 9616066-2020-20085
• Device Sequence Number: 3141251
• Product Code: FPA
• UDI-Device Identifier: 50885403233577
• UDI-Public: 50885403233577
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (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): 10/21/2020

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: Health Professional
• Device Expiration Date: 05/29/2023
• Device Model Number: 10010983
• Device Catalogue Number: 10010983
• Device Lot Number: 20055744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/17/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other