MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC GRIPPER PLUS NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-3468-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that while the normal saline was being flushed, a leaking was noticed at the point of bifurcation of the device.The nurse stopped the infusion procedure and de-accessed the port.The nurse then re-accessed the port with a new huber needle.It was noted that there was no more leaking on the device for the duration of the patient's hospitalization.The original intended procedure was sodium bicarbonate for urine ph running at ordered rate.There was patient involvement, but unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
H3: one device was received for evaluation.No damage or other visual defects were detected in the returned sample.The returned sample was evaluated by introducing distilled water with a syringe to verify that the liquid flowed correctly.Testing of the device identified that the y connector exhibited a crack, which led to leakage confirming the failure mode reported.The reported failure mode will continue to be monitored and if a trend is identified an investigation will be reopened.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 20736355
• Report Number: 9617604-2024-00884
• Device Sequence Number: 15544399
• Product Code: FPA
• UDI-Device Identifier: 10610586033070
• UDI-Public: (01)10610586033070(17)290518(10)6013157
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: 21-3468-24
• Device Lot Number: 6013157
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SODIUM BICARBONATE.
• Patient Age: 69 YR
• Patient Sex: Male