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

Catalog Number	21-2947-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the needle was connected to the syringe for priming, there was resistance and it could not be pushed.The event occurred during priming and no patient harm was reported.It was stated in the report that the patient, a 51-year-old female born on (b)(6) 1973, was given infusion therapy according to the doctor's instructions, and when the needle was connected to the syringe for priming, it was found that there was resistance and could not be pushed.The event occurred during priming.
Additional Manufacturer Narrative
One sample was received.As received no damage or anomalies were observed.In attempts to replicate clinical use a syringe provided by icu medical with black dye was attached to the gripper and fluid was attempted to be pushed through the set.It was observed that fluid would not make it past the y-site.A needle was then used to access the needle port and it was observed that fluid would not make it into the incoming tubing towards the female luer.Upon disassembly visualization of the inner diameter of the junction between the incoming tubing and the y-site, errant solvent was observed.The complaint of needle resistance during syringe connection can be confirmed.The probable cause is due to errant solvent application error during assembly at manufacturer.The lot history was reviewed, no relevant nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: GRIPPER PORT-A-CATH 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: 22167640
• Report Number: 3012307300-2025-06748
• Device Sequence Number: 7818330
• Product Code: FPA
• UDI-Device Identifier: 10610586016776
• UDI-Public: (01)10610586016776(17)290416(10)6006091
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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: Other
• Device Catalogue Number: 21-2947-24
• Device Lot Number: 6006091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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 Age: 51 YR
• Patient Sex: Female