MAUDE Adverse Event Report: COVIDIEN 8888566067 THORACENTESIS TRAY X10; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number 8888566067

Device Problem Difficult to Remove (1528)

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

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reports: ambi had an ascites and a pleural puncture at the gynecological oncology clinic.The thoracentesis/paracentesis set was used twice with two different lot numbers.There is a problem with the separation of the safety sleeve and the trocar sleeve.Only after applying force attempted by 2 people was it possible to loosen the connection (screw cap similar to luer lock).One of the connections had to be cut open with scissors.

Manufacturer Narrative

The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of the lot.One (1) complaint sample was returned to the manufacturing site.The sample was reviewed by a quality engineer.Upon the initial review the thoracentesis catheter was in two separate pieces with the needle removed from the guide sheath.The thoracentesis needle had been removed from the guide sheath by the customer.From the review of the complaint unit no inordinate conditions identified with the catheter other than the needle had been removed from the guide sheath.During the manufacture process, the needle and guide sheath are supplied as one assembly.The design of the thoracentesis catheter is such that once the needle has been withdrawn from the guide sheath it cannot be reinserted as the ball at the top of the luer lock is forced into a location by a spring that prevents reinsertion.This is a safety feature design of the catheter.The most likely root cause for the reported condition is that the unit involved some form of user error.The thoracentesis needle was removed from the guide sheath prior to using the device.When it was attempted to reinsert the needle, this failed because the spring and ball system had blocked the needle path as per the design of the thoracentesis system.The user then attempted to reinsert the needle by opening a glued luer lock connection that is not designed to be opened.At this time, there is not enough information, and a formal corrective/preventative action (capa) will not be initiated, however we will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: 8888566067 THORACENTESIS TRAY X10
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 11643869
• MDR Text Key: 246684224
• Report Number: 9611018-2021-00501
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888566067
• Device Catalogue Number: 8888566067
• Device Lot Number: 20K143FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2021
• Patient Sequence Number: 1