MAUDE Adverse Event Report: ROCHESTER MEDICAL CORP 2130787 ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE 1 28MM BX30

Catalog Number 5283

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that the material that the sheath is made from allegedly feels thinner.

Manufacturer Narrative

Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.The device was not returned.

Event Description

It was reported that the material that the sheath is made from allegedly feels thinner.

• Brand Name: ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE 1 28MM BX30
• Type of Device: CLEAR ADVANTAGE
• Manufacturer (Section D): ROCHESTER MEDICAL CORP 2130787; one rochester medical dr.; stewartville MN 55976
• Manufacturer (Section G): ROCHESTER MEDICAL CORP 2130787; one rochester medical dr.; stewartville MN 55976
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6391300
• MDR Text Key: 69853372
• Report Number: 1018233-2017-00975
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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: Lay User/Patient
• Device Catalogue Number: 5283
• Device Lot Number: NGAW0427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 12/13/2017
• 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