MAUDE Adverse Event Report: ST PAUL GRIPPER PLUS POWER P.A.C. SAFETY HUBER NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-3465-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used sample was received to perform an investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A visual inspection of the returned unit was performed at a distance of 12 to 16 inches under normal conditions of illumination from the device and no obstructions or other workmanship defects were detected in the joins of the product.Functional testing was performed by connecting the sample to a syringe to replicate the failure mode.The water could not flow through the gripper product, the fluid stopped before passing the base.The reported problem of occlusion was confirmed and determined to be caused during manufacturing after the implementation of a solvent dispenser.The maintenance procedure for the dispenser was updated and inspection of product for occlusion was made 100 percent.Operator of device is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was report that upon hospital use, the needle presented great resistance and could not be flushed.No patient injury was reported.

• Brand Name: GRIPPER PLUS POWER P.A.C. SAFETY HUBER NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15462045
• Report Number: 3012307300-2022-19979
• Device Sequence Number: 4688187
• Product Code: FPA
• UDI-Device Identifier: 10610586033049
• UDI-Public: 10610586033049
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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
• Device Expiration Date: 08/14/2024
• Device Model Number: 21-3465-24
• Device Catalogue Number: 21-3465-24
• Device Lot Number: 3854328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown