MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PCA KIT ASV MICROBORE CV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10800175
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
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 medication leaked from the distal port of the pca kit asv microbore cv tubing due to a loose iv set connection.The following information was provided by the initial reporter: "there was no harm to the patient, but the medications was leaking from the distal port of the tubing.The patient was found in a puddle of iv fluids and they were not able to make a tight connection.The medication was wasted and the nurse started a new set up.".
Event or Problem Description
It was reported that medication leaked from the distal port of the pca kit asv microbore cv tubing due to a loose iv set connection.The following information was provided by the initial reporter: "there was no harm to the patient, but the medications was leaking from the distal port of the tubing.The patient was found in a puddle of iv fluids and they were not able to make a tight connection.The medication was wasted and the nurse started a new set up.".
Additional Manufacturer Narrative
H.6.Investigation: a sample was received and tested by our quality team.The luer was clearly cracked and the customer's complaint of leak has been verified.Microscope analyses was employed to determine possible root causes of this failure.Root cause was not determined but it is known that this failure has occurred when the luer has been over tightened in the past.A device history record review could not be performed because a lot number was not provided by the customer.H3 other text : see h.10.

• Brand Name: PCA KIT ASV MICROBORE CV
• 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: 11548417
• Report Number: 9616066-2021-50534
• Device Sequence Number: 3844795
• Product Code: FPA
• UDI-Device Identifier: 50885403234406
• UDI-Public: 50885403234406
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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): 04/19/2021

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: 10800175
• Device Catalogue Number: 10800175
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1