MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SUCTION TUBE MCLT50 MALLEAB BLUNT TERRIS; PFM11

Catalog Number MCLT50

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

Product was returned for evaluation.There was one malleable blunt suction tube returned used/processed showing wear with the complaint that there is tissue in the tube.Lot number was not received to perform device history record review.Instrument was checked under the microscope and could not detect anything in the tube.In addition, water flow testing was completed by having the water run through the top of the instrument and it drained down the two holes at the bottom freely.This complaint is unconfirmed.Could not duplicate reported incident.No manufacturing, workmanship, or material deficiency has been identified.

Event Description

A sales specialist reported on behalf of the customer that on (b)(6) 2019, an mclt50 suction tube malleab blunt terris was contaminated with tissue debris.The reported issue was discovered prior to use.The patient was being prepped in the or (operating room) for a thyroidectomy (incision) procedure.There was no patient contact, and no patient injury reported.The action that was taken after the product problem occurred was that the product was removed from the sterile field, decontaminated, and flash sterilized.A 20-minute surgical delay with no adverse consequences was reported.No revision/medical intervention was required.Product was then used in the thyroidectomy case.

• Brand Name: SUCTION TUBE MCLT50 MALLEAB BLUNT TERRIS
• 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8744938
• MDR Text Key: 149677132
• Report Number: 2523190-2019-00087
• Device Sequence Number: 1
• Product Code: KAC
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCLT50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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