MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXTENSION SETS - 20" STANDARD-BORE IV EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	30202E
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6 investigation summary: a complaint of the wrong product being inside the box was received from the customer.No product or photo was returned by the customer.The customer complaint of packaging issue - mixed product 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 30202e because the lot number is unknown.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.E1.Address information was not able to be obtained, therefore, nj was used as a place holder.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd extension sets - 20" standard-bore iv extension set has a different identification than the box.The following information was provided by the initial reporter: wrong products boxed in the case of product "case of item 30202e, in the case was item 22059e(12 ea.) " (per customer).

• Brand Name: BD EXTENSION SETS - 20" STANDARD-BORE IV EXTENSION SET
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17078821
• Report Number: 9616066-2023-01116
• Device Sequence Number: 2250355
• Product Code: FPA
• UDI-Device Identifier: 37613203011540
• UDI-Public: (01)37613203011540
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 05/23/2023

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: 30202E
• Device Catalogue Number: 30202E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown