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

Model Number 21-3251-24

Device Problem Material Twisted/Bent (2981)

Patient Problem Swelling/ Edema (4577)

Event Type  malfunction  

Event Description

It was reported that when attempting to access the patient's port, it was noted to be very mobile and difficult to access.It was difficult to remove the safety needle and unable to obtain flashback or flush the line.A small adjustment was made and then the line was able to be flushed with 1-2 mls of saline.The port was removed.A blunt cannula was noted to be bent upwards approximately 45 degree from perpendicular form.There was a small amount of swelling and bleeding at the port site.The patient was sent to the hospital for further review and assessment.No medical or surgical intervention was reported.

Manufacturer Narrative

No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was performed, and no issues were noted during manufacture.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA
• 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: 15334517
• MDR Text Key: 305536910
• Report Number: 3012307300-2022-17202
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029745
• UDI-Public: 10610586029745
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 21-3251-24
• Device Catalogue Number: 21-3251-24
• Device Lot Number: 3885530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1