MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC NON-Y-SITE GRIPPER NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2735-24
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
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 reportable information becomes available.
Event or Problem Description
It was reported that when the clamp was opened, the hose drew in air, despite previously being air-free and flushed.There was patient involvement, but no patient injury.The incident took place right at the start of using the product, involving healthcare professionals, and occurred at the patient's home.
Additional Manufacturer Narrative
One device was returned.Visual and functional testing were performed.During the functional test the distilled water passed through the sample without difficulty, the sample worked as expected.The customer's problem was not confirmed.The root cause was not determined as no problem found.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: DELTEC NON-Y-SITE GRIPPER NEEDLE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19981745
• Report Number: 9617604-2024-00650
• Device Sequence Number: 18236374
• Product Code: FPA
• UDI-Device Identifier: 10610586015861
• UDI-Public: (01)10610586015861(17)271110(10)4343135
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K870866
• 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): 09/13/2024

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: 21-2735-24
• Device Lot Number: 4343135
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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