MAUDE Adverse Event Report: FUJIMORI KOGYO ANGIO KIT PRESSURE MONITORING ACC; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number CSA3009Z_

Device Problems Hole In Material (1293); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specification at the time of release.Received one inflation device in original pouch.One side (right side) of pouch was found opened at the area from approximately 16.5-30cm from top of the pouch.A thin trace which pouch film had been sealed to tyvek sheet was observed on the film side.

Event Description

It was reported that one side of the pouch was found to be opened.There were no problems with the pouch of the other 4 kits.The distributor did not open the box at their site before delivery.It could not be confirmed from the customer how they store the device in the hospital.There were no patient complications reported.

• Brand Name: ANGIO KIT PRESSURE MONITORING ACC
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): FUJIMORI KOGYO; 1109-1 shibaide kuramochi-; nabari mie; JA
• Manufacturer (Section G): FUJIMORI KOGYO; 1109-1 shibaide kuramochi-cho; nabari mie; JA
• Manufacturer Contact: lynn selawski ; 9497564386
• MDR Report Key: 5232797
• MDR Text Key: 31484651
• Report Number: 2015691-2015-03132
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSA3009Z_
• Device Lot Number: FK0574LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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