MAUDE Adverse Event Report: TRI-STATE DE MEXICO MEDLINE; CMH PORT ACCESS KIT

Catalog Number	EBSI1789A
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "the syringe cracked at the hub connection site" after "flushing the patient's iv line using a prefilled syringe supplied in the port access kit." the customer reported that they "attached a new prefilled syringe from the same kit to continue flushing the line" and that "after completing the flush and removing the second syringe, that syringe also cracked at the hub connection site." the customer stated, "a small fragment of plastic from the syringe tip had remained within the iv hub" which "compromised the integrity of the connection, allowing blood backflow from the patient's iv line." per the customer, the "entire iv line was removed and a new line was initiated." the customer said that "the patient remained stable throughout the event with no reported discomfort or adverse symptoms." no additional details are available related to the customer reported issue.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 "the syringe cracked at the hub connection site" after "flushing the patient's iv line using a prefilled syringe supplied in the port access kit." the customer reported that they "attached a new prefilled syringe from the same kit to continue flushing the line" and that "after completing the flush and removing the second syringe, that syringe also cracked at the hub connection site." the customer stated, "a small fragment of plastic from the syringe tip had remained within the iv hub" which "compromised the integrity of the connection, allowing blood backflow from the patient's iv line." per the customer, the "entire iv line was removed and a new line was initiated.".

• Brand Name: MEDLINE
• Common Device Name: CMH PORT ACCESS KIT
• Manufacturer (Section D): TRI-STATE DE MEXICO; s. de r.l. de c.v; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24690586
• Report Number: 3004519921-2026-00009
• Device Sequence Number: 9984999
• Product Code: OXQ
• UDI-Device Identifier: 10653160387886
• UDI-Public: 10653160387886
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/25/2026

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 Expiration Date: 06/30/2026
• Device Catalogue Number: EBSI1789A
• Device Lot Number: 2025050790
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown