MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PCA KIT Y CONN CHECK VLV 90 INCH; 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	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 pca kit y conn check vlv 90 inch was deformed/damaged/cracked.The following information was provided by the initial reporter: material no.: 10800175.Batch no.: unknown.Pt stated that her pca tubing was leaking.Rn assessed and noted that leak was not coming from syringe or connections.Pca stopped and tubing removed.After inspection of the tubing a small crack was noted in the line.New tubing for both pca and hydration were changed.
Event or Problem Description
It was reported that the pca kit y conn check vlv 90 inch was deformed/damaged/cracked.The following information was provided by the initial reporter: material no.: 10800175 and batch no.: unknown.Pt stated that her pca tubing was leaking.Rn assessed and noted that leak was not coming from syringe or connections.Pca stopped and tubing removed.After inspection of the tubing a small crack was noted in the line.New tubing for both pca and hydration were changed.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint of crack with leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 10800175 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: PCA KIT Y CONN CHECK VLV 90 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
• MDR Report Key: 12089761
• Report Number: 9616066-2021-51428
• Device Sequence Number: 17334555
• Product Code: FPA
• UDI-Device Identifier: 50885403234406
• UDI-Public: 50885403234406
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/01/2021

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?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1