MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SUCTION TUBE MCEN134 110MM MALLE WORMALD; PFM11

Catalog Number MCEN134

Device Problem Break (1069)

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

Event Date 11/08/2022

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 during an operation, the welded part located about 5cm from the edge of the malle wormald suction tube (mcen134) was damaged.It was reported that there was a risk that broken pieces may remain in the body, as the device was in contact with the patient.There was no surgical delay; however, it is unknown whether patient injury occurred.

Manufacturer Narrative

The malle wormald suction tube (mcen134) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the malle wormald suction tube verified the complaint reported by the customer as valid.The suction tube was received loosened from the other tube at the bottom.Evaluation observed that there was traces of the laser weld, indicating the laser weld of the tube was compliant when it was manufactured.Evaluation also noted that when there is a small gap between the two tubes, it can unsolder the two tubes when the tube is used and twisted.Root cause analysis: it was noted there was a bit of emptiness (gap) between the tube and the handle which can weaken the laser welding.

Event Description

N/a.

• Brand Name: SUCTION TUBE MCEN134 110MM MALLE WORMALD
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15890875
• MDR Text Key: 305254628
• Report Number: 3003249645-2022-00045
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

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 Catalogue Number: MCEN134
• Device Lot Number: 6015114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1