MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SUCTION TUBE MCO771-3-0 DIA 3.0MM LEMPER; PFM11

Catalog Number MCO771-3-0

Device Problem Break (1069)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the suction tube (mco771-3-05) purchased in 2021 was broken.It is unknown whether the product was in use on a patient or if there was an increase in surgery time.However, it was reported that no patient injury or death occurred.

Manufacturer Narrative

The suction tube (mco771-3-05) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the evaluation verified the complaint as valid.The tube is broken near the welding; however, no manufacturing defect was found, and the quality of the welding is good.Root cause - considering that there is no manufacturing defect, this issue is probably due to a bad handling of the device during the storage or the reprocessing.

• Brand Name: SUCTION TUBE MCO771-3-0 DIA 3.0MM LEMPER
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 12316572
• MDR Text Key: 268063087
• Report Number: 2523190-2021-00181
• Device Sequence Number: 1
• Product Code: JZF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCO771-3-0
• Device Lot Number: 5109045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 08/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1