MAUDE Adverse Event Report: NULL BLUPERC AND BLUGRIGGS PERCUTANEOUS DILATION KITS; CA13B0/4K2/000JP

Catalog Number CA13B0/4K2/000JP

Device Problem Leak/Splash (1354)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated and the device passed all functional tests.Dhr review was done, no issues related to the original complaint were found.

Event Description

It was reported that during the pre-use check, leakage of air from the breathing circuit was observed.No patient injury.No additional information is available for this complaint.

• Brand Name: BLUPERC AND BLUGRIGGS PERCUTANEOUS DILATION KITS
• Type of Device: CA13B0/4K2/000JP
• Manufacturer (Section G): NULL
• MDR Report Key: 13563641
• MDR Text Key: 286246318
• Report Number: 3012307300-2022-03696
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2022

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: CA13B0/4K2/000JP
• Device Lot Number: 211201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1