MAUDE Adverse Event Report: MEDLINE - MEXICALI; MTS,KIT,ACCESSORY,SAN DIEGO

Catalog Number	VASC1232
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, "packaging is crumpled on a large portion of the packages.Some perforated with broken stopcocks.When unpacking from boxes the packages they were visible crunched.When opening its contents there were visibly broken and bent components." a sample is available for evaluation.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(6) on (b)(6) 2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
According to the customer, "packaging is crumpled on a large portion of the packages.Some perforated with broken stopcocks.When unpacking from boxes the packages they were visible crunched.When opening its contents there were visibly broken and bent components.".

• Common Device Name: MTS,KIT,ACCESSORY,SAN DIEGO
• Manufacturer (Section D): MEDLINE - MEXICALI; calle circuito del desierto#71; parque industrial del desierto; mexicali baja california, 21383 ; MX 21383
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19169427
• Report Number: 3015173212-2024-00001
• Device Sequence Number: 12626581
• Product Code: LRO
• UDI-Device Identifier: 40193489444002
• UDI-Public: 40193489444002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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
• Device Catalogue Number: VASC1232
• Device Lot Number: (10)23IMA251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown