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

Catalog Number 21-2768-24

Device Problems Detachment of Device or Device Component (2907); Fail-Safe Did Not Operate (4046)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that the safety mechanism was triggered when the deltec gripper plus needle was removed.When placing the needle on a surface, it suddenly jumps apart, the safety mechanism detaches, and the needle is then exposed.There were no adverse events reported.

Manufacturer Narrative

No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.Six (6) pictures attached for evaluation: observe safety mechanism detached, broken.The sample consist of one (1); the returned sample was received decontaminated without its original packaging.Functional test: activated the safety mechanism to see if there was any issue.Observe safety mechanism was broken, the failure mode reported was confirmed.The most probable root cause is that the product became damaged after it left manufacturing facility.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.Production personnel was notified by quality engineer on 25/feb/2021 as awareness of the defect reported by the customer.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 11304415
• MDR Text Key: 231109834
• Report Number: 3012307300-2021-01090
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-2768-24
• Device Lot Number: 4016329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1