MAUDE Adverse Event Report: PERFUSION SYSTEMS "DLP MACRO SUCTION TUBE, 20 FR"; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTAB

Model Number 10061

Device Problem Fracture (1260)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

Medtronic received information that during use of a dlp suction tube, the customer reported that when the staff opened up the nurses pack and proceeded to use the suction tube at the field, they noticed the plastic tip was broken off of the suction tube.At that point, they looked for the missing piece and found it on the back table still in the nurses pack and then removed the suction tube and the broken piece from the field.This suction tube arrived in the pack broken. the suction tube was replaced to complete the procedure.There was no patient impact associated with this event.Additional information received states that there was no damage to any part of the packaging and to any other device in the same box besides the suction tube with the alleged issue.

Manufacturer Narrative

Product analysis: visual inspection showed that the tip was broken off.The reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: "DLP MACRO SUCTION TUBE, 20 FR"
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTAB
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13887572
• MDR Text Key: 287822392
• Report Number: 2184009-2022-00046
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10061
• Device Catalogue Number: 10061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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