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

Catalog Number	21-2734-24
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.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 the port needle was not bent when inserted, but when changing it after 7 days, the tip of the needle was bent.This occurred with 2 needles.There was patient involvement, but no patient harm/adverse events reported.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: two used units were decontaminated and received for evaluation.The complaint samples were visually inspected, at 12¿ to 16¿ under normal conditions of illumination.The two samples were returned cut, only the bases with needles were returned.The failure mode reported in the complaint was confirmed; however, it cannot be concluded that the parts were damaged in the manufacturing process because the samples were received fully manipulated.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 lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19362482
• Report Number: 9617604-2024-00468
• Device Sequence Number: 6415426
• Product Code: FPA
• UDI-Device Identifier: 10610586015854
• UDI-Public: (01)10610586015854(17)251110(10)4071848
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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 Expiration Date: 11/10/2025
• Device Catalogue Number: 21-2734-24
• Device Lot Number: 4071848
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/09/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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