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

Catalog Number	21-2961-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the cleaning of the device with saline, the nurse noticed a leak at the y-site.The plastic tube appears to be broken on half of the diameter of the rigid plastic base.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
No device or device photo was returned for investigation.Functional and visual testing could not be performed and no confirmation due to no device returned.Due to this, no root cause was determined.The device history review of the reported lot number found no non-conformities during the manufacturing process.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: received one (1) used.List #21-2961-24, ndl, gripper plus, 22g x.75" (19mm), needleless y-site 12/bx; lot #4463747.As received, noticed the tubing partially separated from the y junction.No other damage or anomalies observed.One (1) photograph was provided by the customer showing the location of the leak.Confirmed complaint of broken tubing, probable cause, excess solvent and unintentional bending force.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 GRIPPER PLUS
• 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: 20301361
• Report Number: 9617604-2024-00756
• Device Sequence Number: 8783295
• Product Code: FPA
• UDI-Device Identifier: 10610586027697
• UDI-Public: (01)10610586027697(17)290228(10)4463747
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 21-2961-24
• Device Lot Number: 4463747
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown