MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 20G 8CM

Catalog Number M120080

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 12/02/2014

Event Type  malfunction  

Event Description

(b)(6) 2014 it was reported.Registered nurse attempted to place midline catheter, allegedly met resistance, reported that when removed, catheter end of catheter was broken 1.5 cm shorter than prior to insertion.

Manufacturer Narrative

A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.The device has not been returned to the manufacturer, at this time, for evaluation.

• Brand Name: POWERGLIDE MIDLINE CATHETER, 20G 8CM
• Manufacturer (Section D): BARD ACCESS SYSTEMS; salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 4381570
• MDR Text Key: 5120289
• Report Number: 3006260740-2014-00633
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121073
• 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: 12/08/2014

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: M120080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention