MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. NDL, GRIPPER PLUS, 22G X .625" (16MM) 12/BX; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2770-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
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 "when priming, the needle tip cannot be filled due to resistance.There seems to be a blockage along the way".The event occurred during priming, no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection found damages and defects on the product.The returned sample was evaluated by introducing distilled water with a syringe to verify that the liquid flowed correctly.No occlusion was observed; the reported failure mode is not confirmed.No further actions were taken since the reported issue was not confirmed.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: NDL, GRIPPER PLUS, 22G X .625" (16MM) 12/BX
• 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: 21152401
• Report Number: 9617604-2025-00055
• Device Sequence Number: 13058884
• Product Code: FPA
• UDI-Device Identifier: 10610586025631
• UDI-Public: (01)10610586025631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 21-2770-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown