MAUDE Adverse Event Report: ST PAUL DELTECGRIPPER MICRO BLUNT CANNULA, NON-CORING SAF; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-2947-24

Device Problem Blocked Connection (2888)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

No product was returned, thus the failure mode reported could not be investigated and a 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 (b)(4) , as a result of warning letter cms# (b)(4).

Event Description

It was reported that, during the maintenance process of the infusion port, when the implantable intravenous drug delivery system package was removed to give exhaust, it was found that it could not be exhausted normally.Other loops on the implanted intravenous drug delivery system were checked.There is no problem with the joints, and the needle is suspected to be clogged.It was replaced with a new implantable drug delivery system with no issues.No patient injury was reported.

• Brand Name: DELTECGRIPPER MICRO BLUNT CANNULA, NON-CORING SAF
• 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; dongying district; minneapolis, MN 55442
• MDR Report Key: 15397416
• MDR Text Key: 304307926
• Report Number: 3012307300-2022-18447
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586016776
• UDI-Public: 10610586016776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K870866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2947-24
• Device Catalogue Number: 21-2947-24
• Device Lot Number: 4080896
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1