MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. HEMODIALYSIS CATHETER

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

Complainant stated that the equistream catheters are allegedly packed too tightly in the boxes when they are shipped.She reported that this causes unnecessary product waste due to cutting the product while opening the boxes.

Manufacturer Narrative

The device has not been returned to the mfr for eval.A lot history review (lhr) review is not possible, as no mfg lot number has been provided by the complainant.

• Brand Name: HEMODIALYSIS CATHETER
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS INC.; salt lake city UT
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 4376791
• MDR Text Key: 5119079
• Report Number: 3006260740-2014-00628
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/15/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention