MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-2960-24

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2021

Event Type  malfunction  

Event Description

It was reported that the customer attempted to pass physiological saline solution through the infusion line with the clamp released, but the solution did not flow properly.No patient injury was reported.

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No problems or issues were identified during this device history record review.One sample was received, decontaminated; the sample was received in used condition with its open original package.During the functional testing, the unit sample was found occluded.The failure mode reported was confirmed.The root cause is excess solvent in the component bonding operation.Awareness notification was made to production personnel for the occlusion failure mode.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16916245
• MDR Text Key: 315369076
• Report Number: 3012307300-2023-05608
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027680
• UDI-Public: 10610586027680
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2023

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 Operator: Health Professional
• Device Model Number: 21-2960-24
• Device Catalogue Number: 21-2960-24
• Device Lot Number: 4046734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Race: Asian