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

Catalog Number	21-3465-24
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
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 while purging, they noticed that it was not possible to purge the product from the distal end, if they accessed from the connector, they could purge the top part, but not the distal end.There was no reported patient involvement, and no harm reported.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: one photo and one sample were received for evaluation.The sample was visually inspected and no damage or anomalies were observed.During the functional testing, in attempts to replicate clinical use the set was attached to a syringe with black dye and priming was attempted.No flow was observed to make it into the set.Further inspection of the inner diameter of the female luer showed errant solvent blocking the fluid path.A needle was used to puncture the solvent blockage, and the set was able to be successfully primed.The complaint of not being able to purge from the distal end can be confirmed.The probable cause is due to a solvent application error at the manufacturer.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 20347947
• Report Number: 9617604-2024-00772
• Device Sequence Number: 8053681
• Product Code: FPA
• UDI-Device Identifier: 10610586033049
• UDI-Public: (01)10610586033049(17)290421(10)6006119
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072657
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 21-3465-24
• Device Lot Number: 6006119
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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