MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2734-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle obstruction does not allow liquid through.No patient injury reported.
Additional Manufacturer Narrative
The returned sample was received decontaminated and in used condition without its original package.One unit was tested for occlusion by introducing water with a syringe.The water flows; no occlusion found in the returned sample, see video attach.The failure mode reported was not confirmed.Based on the analysis conducted in the sample provided, the complaint was not confirmed.No corrective actions were taken since the complaint was not confirmed.No device history record review was performed.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA
• 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; moderna; minneapolis, MN 55442
• MDR Report Key: 15334483
• Report Number: 3012307300-2022-17201
• Device Sequence Number: 6956410
• Product Code: FPA
• UDI-Device Identifier: 10610586015854
• UDI-Public: 10610586015854
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2026
• Device Model Number: 21-2734-24
• Device Catalogue Number: 21-2734-24
• Device Lot Number: 4095639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• 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: 04/18/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• 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