MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. TUBE CEV649-5B DIA 5MM 350MM; PFM16

Catalog Number CEV649-5B

Device Problem Solder Joint Fracture (2324)

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

Event Date 11/25/2022

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 before the sterilization of the 5mm dia tube (cev649-5b), the coating around the laparoscopic tube was not yet welded.Medical staff discovered dry blood inside indicating sealing problem.It was reported that the units had 72 sterilization runs.It was indicated that there was no consequences to the patient but this type of issue could lead to biological risk.This is an isolated event.

Manufacturer Narrative

B5: a facility reported that before the sterilization of the 5mm dia tube (cev649-5b), the sheath surrounding the laparoscopy tube became untied.Medical staff discovered dry blood inside indicating sealing problem.It was reported that the units had 72 sterilization runs.It was indicated that there was no consequences to the patient but this type of issue could lead to biological risk.This is an isolated event.Investigation findings: the 5mm dia tube (cev649-5b) was returned for evaluation.The reported lot number ot22255 is not a valid lot number for this instrument; therefore, a dhr was unable to be performed.Evaluation verified the complaint reported by the customer as valid.The sheath was off the tube.The tube was dirty and bent.Considering the age of the instrument and the absence of maintenance by integra microfrance, we can reasonably conclude that this event is due to a normal wear.Therefore, we consider that the event is not attributable to integra microfrance.

Event Description

N/a.

• Brand Name: TUBE CEV649-5B DIA 5MM 350MM
• Type of Device: PFM16
• 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: 16068683
• MDR Text Key: 308237616
• Report Number: 3003249645-2022-00049
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K993655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CEV649-5B
• Device Lot Number: OT22255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2014
• 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