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

Catalog Number	21-2965-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
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 the gripper leaks through the unused two-way valve without obstructing the main line.The patient received some of the injected medication on his shirt due to the leaky valve, without any further consequences.There was patient involvement, but no patient harm/adverse event reported.
Additional Manufacturer Narrative
One (1) sample was returned for evaluation without its original packaging, inside a plastic bag in decontaminated condition with the needle activated and with missing component luer cap.The sample was evaluated by introducing distilled water with a syringe to verify that the liquid flowed correctly.During the functional test it was detected that the distilled water passed through the sample without difficulty, no leaks were detected in the sample.The complaint was not confirmed/duplicated.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• 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: 19511531
• Report Number: 9617604-2024-00517
• Device Sequence Number: 3394208
• Product Code: FPA
• UDI-Device Identifier: 10610586027734
• UDI-Public: (01)10610586027734(17)280901(10)4422435
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 21-2965-24
• Device Lot Number: 4422435
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/23/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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