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

Model Number 21-2966-24

Device Problem Reflux within Device (1522)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The returned samples (10) were received decontaminated with its original closed packaging.The samples were tested with a syringe to replicate the failure mode.No occlusion was detected; the complaint was not confirmed and root cause could not be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

Event Description

It was reported that there was no blood reflux despite attempts with the same sample.There were no issues identified the previous times.No patient injury was reported.

• Brand Name: DELTEC GRIPPER PLUS SAFETY NEEDLES
• Type of Device: 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: 15397871
• MDR Text Key: 303408701
• Report Number: 3012307300-2022-18555
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027741
• UDI-Public: 10610586027741
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2966-24
• Device Catalogue Number: 21-2966-24
• Device Lot Number: 3938275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1