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

Catalog Number	21-3367-24
Medical Device Problem Codes	Complete Blockage (1094); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that, while flushing and sealing the tubes of the product, the blood at the tip of the product could not be flushed out and gathered at the connection between the needle tail and the catheter.This condition occurred after five consecutive replacements.The customer reported that if blood aggregated and accumulated to form a thrombus that entered the veins, it would have a serious impact on the patient.No specific patient harm/adverse event was reported.
Additional Manufacturer Narrative
Received two used devices, one (1) customer image and two (2) customer videos were returned showing the residual blood within the tubing-needle area.As received, there were no damages or anomalies observed.In order to replicate clinical use, the samples were connected with an icu medical provided syringe, and flushing was performed.No difficulties in flushing were observed.No occlusions were observed.The samples were tested again using simulated blood, sharing the color and viscosity of human blood.The simulated blood does not have any inherent coagulating properties.After the samples were flushed, the needle was submerged, and fluid was withdrawn.This was repeated five times, infusing and withdrawing simulated blood using an icu medical provided syringe.During inspection of the gap at the tubing-needle connection, simulated blood residue was observed indicating a leak.However, the complaint of an occlusion cannot be confirmed nor replicated.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• 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: 22061493
• Report Number: 3012307300-2025-05932
• Device Sequence Number: 8469380
• Product Code: FPA
• UDI-Device Identifier: 10610586033001
• UDI-Public: (01)10610586033001(17)291002(10)6061434
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 21-3367-24
• Device Lot Number: 6061434
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown