MAUDE Adverse Event Report: MEDLINE INDUSTRIES - PDM; PORT ACCESS INSERT OUTPNT

Catalog Number	CVI5190A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that " saline flush in the kit was broken around the plunger and cracked along the side.The contents of the flush had leaked inside the kit damaging the other products.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-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
Syringe leaked within kit.

• Common Device Name: PORT ACCESS INSERT OUTPNT
• Manufacturer (Section D): MEDLINE INDUSTRIES - PDM; blvd. world trade center no.10; parque industrial oradel, nuev; tamaulipas, 88285 ; MX 88285
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22079083
• Report Number: 3004122598-2025-00003
• Device Sequence Number: 8530841
• Product Code: OFF
• UDI-Device Identifier: 10198459107283
• UDI-Public: 10198459107283
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: CVI5190A
• Device Lot Number: 24KBU593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown