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

Catalog Number	10012564
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that gra set v/nv qs mc 60d 3sstubing broke.This occurred on 10 occasions.The following information was provided by the initial reporter: material no: 10012564 batch no: 20096477.It was reported that the bottom piece on the tube comes off during surgery.
Additional Manufacturer Narrative
H.6.Investigation: a complaint of the bottom part of the set coming loose and separating was received from the customer.One sample was returned for investigation.Through visual inspection, the customer complaint was verified.The bottom component of the buretrol had separated.When getting a closer look under the microscope, no solvent could be seen on either components.A device history record review for model 10012564 lot number 20096477 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this defect is an insufficient amount of solvent being added to the connection site.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of loose component with lot #20096477 regarding item 10012564.
Event or Problem Description
It was reported that gra set v/nv qs mc 60d 3sstubing broke.This occurred on 10 occasions.The following information was provided by the initial reporter: material no: 10012564 batch no: 20096477.It was reported that the bottom piece on the tube comes off during surgery.

• 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: 11794877
• Report Number: 9616066-2021-50939
• Device Sequence Number: 3948894
• Product Code: FPA
• UDI-Device Identifier: 10885403233746
• UDI-Public: 10885403233746
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 05/10/2021

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 Catalogue Number: 10012564
• Device Lot Number: 20096477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1