MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	21-3257-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient arrived at the pediatric emergency department at approximately 2030 with leakage observed from the port tubing while a home blinatumomab infusion was running.The leakage was identified at the bottom of the port needle line before connection to the chemotherapy adapter, and the infusion was closely monitored and subsequently paused at approximately 2125 for port reaccess.Blood return was verified, and blinatumomab was restarted at 2145 at a rate of 5 ml per hour by s.Morris, rn, and d.Hopkins, rn.The leaking port needle had been placed at the outpatient clinic on 20-apr-26, and the clinic needle was retained with this report.There was a patient involvement with no harm.
Additional Manufacturer Narrative
H3: investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25243173
• Report Number: 3012307300-2026-05274
• Device Sequence Number: 9562912
• Product Code: FPA
• UDI-Device Identifier: 10610586029806
• UDI-Public: (01)10610586029806(17)281013(10)4435133
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: Health Professional
• Device Catalogue Number: 21-3257-24
• Device Lot Number: 4435133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown