MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - MEXICALI; PORT ACCESS TRAY

Catalog Number	DT21830B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on 3/23/2026, "rn reported broken sterile ns syringe, from ivad access kit.When attempting to flush ivad after access and applying pressure to plunger, "wings" on either side of the syringe broke off, exposing sharp plastic edges.Edges did break skin and cause bleeding to rn.Clinician completed procedure with another product, saved malfunctioning product, addressed injury and reported incident".According to the customer contact, "injury to rn is resolved".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
It was reported that on 3/23/2026, "rn reported broken sterile ns syringe, from ivad access kit.".

• Common Device Name: PORT ACCESS TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - MEXICALI; calle circuito del desierto #7; parque industrial del desierto; mexicali baja california, 21383 ; MX 21383
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25086846
• Report Number: 3015173212-2026-00007
• Device Sequence Number: 16085221
• Product Code: LRO
• UDI-Device Identifier: 10653160353461
• UDI-Public: 10653160353461
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DT21830B
• Device Lot Number: 2026020390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2026
• 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