MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRAVITY SET V/NV CKV 3SS 10DP; INTRAVASCULAR ADMINISTRATION SET

Model Number	41134E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: two used gravity sets, model 41134e lot 21039516, was received by the customer for investigation.An extension set was also received with the samples.Upon visual inspection, it could be observed that one of the set's second smartsite needleless connectors was disconnected from the tubing.No other defects were observed.Visual inspection under magnification was performed on both the internal and external tubing engagement components of the separated set.It could be identified that the solvent had not been properly applied to the tubing during the assembly process.The second set was examined under magnification as well.The top smartsite component was observed to be partially separated.It could be identified that the tubing had not been fully inserted during the assembly process.The customer's complaint of tubing 41134e leaking in surgery pre op was verified.A device history record review for model 41134e lot number 21039516 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 2 gravity set v/nv ckv 3ss 10dp experienced leakage.The following information was provided by the initial reporter: material #: 41134e, batch/lot #: 21039516.There has been two separate instances where tubing 41134e has leaked in surgery pre op.After the second one, i traded out tubing from central.I kept the tubing with lot# (10)21039516, along with the two that had leaked.The leakage each time was at a different check valve/injection site.

• Brand Name: GRAVITY SET V/NV CKV 3SS 10DP
• 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: 12081099
• Report Number: 9616066-2021-51407
• Device Sequence Number: 17232964
• Product Code: FPA
• UDI-Device Identifier: 50885403235281
• UDI-Public: 50885403235281
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 06/14/2021

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: 03/10/2024
• Device Model Number: 41134E
• Device Catalogue Number: 41134E
• Device Lot Number: 21039516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1