MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 20G 10CM; FOZ

Catalog Number M120100

Device Problems Break (1069); Kinked (1339); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 - it was reported that upon advancement, the catheter allegedly bunched.Healthcare provider reported the catheter, needle and wire were all removed at the same time, in unison, alleged mild resistance reported.It was reported upon examination of catheter, wire and needle revealed approximately 4cm of the catheter not present.Ultrasound examination in cross sectional and longitudinal views reportedly shows the partial catheter in the basilic vein, approximately a 4cm portion, end to end.It was said the veinous tourniquet left in place and tied secure above the catheter.

Manufacturer Narrative

The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reyg0782 showed one other similar product complaint(s) from this lot number.

• Brand Name: POWERGLIDE MIDLINE CATHETER, 20G 10CM
• Type of Device: FOZ
• 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: 4383638
• MDR Text Key: 16174167
• Report Number: 3006260740-2014-00636
• 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: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M120100
• Device Lot Number: REYG0782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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