MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10 INCH EXT W/ 0.2 PED & VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number	20029E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the "filter dame" came apart from the 10 inch  ext w/ 0.2 ped & vlv port extension set during use.The following information was provided by the initial reporter: "filter dame apart from the tubing extension set.".
Additional Manufacturer Narrative
H6: investigation summary the customer reported the tubing came apart at the filter site, and returned the used sample of model #20029e.The sample clearly separated at the outlet of the filter, and the complaint is verified.The insertions depth appeared to be fine, and dimensional analysis found the tubing to be within tolerance.No other failure modes were observed.A device history record review could not be performed because a valid lot number was not provided by the customer.Visual inspection under the microscope determined the root cause to be insufficient solvent.This incident has been added to our database of reported incidents.H3 other text : see h10.
Event or Problem Description
It was reported that the "filter dame" came apart from the 10 inch  ext w/ 0.2 ped & vlv port extension set during use.The following information was provided by the initial reporter: "filter dame apart from the tubing extension set".

• Brand Name: 10 INCH EXT W/ 0.2 PED & VLV PORT
• 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
• MDR Report Key: 11957375
• Report Number: 9616066-2021-51271
• Device Sequence Number: 17079214
• Product Code: FPA
• UDI-Device Identifier: 50885403234864
• UDI-Public: 50885403234864
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/10/2021

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 Model Number: 20029E
• Device Catalogue Number: 20029E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1