MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRAV SET 20DP V/NV W/CKV 3SS 104-IN; INTRAVASCULAR ADMINISTRATION SET

Model Number	42493E
Medical Device Problem Codes	Component Missing (2306); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a complaint of a missing roller clamp was received from the customer.A sample was provided to aid in the investigation of this defect.Through visual inspection, the customer complaint was verified.The roller clamp was not assembled with the set.A device history record review for model 42493e lot number 21029646 was performed.The search showed that a total of 14,403 units in 1 lot number was built on 18feb2021.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 assembly error during the manufacturing of this set.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that a grav set 20dp v/nv w/ckv 3ss 104-in had a missing roller clamp before use.The following was reported by the initial reporter: "there's no roller clamp it came missing".

• Brand Name: GRAV SET 20DP V/NV W/CKV 3SS 104-IN
• 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: 11881108
• Report Number: 9616066-2021-51141
• Device Sequence Number: 1413335
• Product Code: FPA
• UDI-Device Identifier: 50885403235373
• UDI-Public: 50885403235373
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: 42493E
• Device Catalogue Number: 42493E
• Device Lot Number: 21029646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1