MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRA SET V/NV QS MC 60D 3SS; INTRAVASCULAR ADMINISTRATION SET

Model Number	10012564
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a complaint of the bottom part of the buretrol coming loose was received from the customer.No product or photo was returned by the customer.The customer complaint of loose component could not be verified due to the product not being returned for failure investigation.A device history record review for model 10012564 lot number 20106218 was performed.The search showed that a total of 6,003 units in 1 lot number was built on 23oct2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause 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.
Event or Problem Description
It was reported that 3 gra sets v/nv qs mc 60d 3ss leaked from the bottom of the tube during use.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "the bottom of the tube would either leak really bad or just pop off like there is no glue on it.They did check the product prior to spiking the iv and stated it seemed to be fine, but after the iv fluid sat in there for a little bit the bottom came off or started leaking really bad.Our doctors are very concerned regarding this.".

• Brand Name: GRA SET V/NV QS MC 60D 3SS
• 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: 11823128
• Report Number: 9616066-2021-50991
• Device Sequence Number: 4444074
• Product Code: FPA
• UDI-Device Identifier: 50885403233744
• UDI-Public: 50885403233744
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K951922
• 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
• Report Date (Section B): 04/29/2021

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 Expiration Date: 10/23/2023
• Device Model Number: 10012564
• Device Catalogue Number: 10012564
• Device Lot Number: 20106218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1