MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (8CM); INTRAVASCULAR CATHETER

Catalog Number	M120081
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rezl0991 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
On (b)(6) 2016- per sales representative, user facility reported that a rn was placing a powerglide.Access was achieved and the wire deployed easily but then the catheter mechanism seemed to "malfunction".It was said that the catheter "jammed up" on itself and the rn could not remove it.Another rn attempted to remove the device and succeeded.After the removal of the device it appeared to be fractured.Another powerglide was successfully placed in the patient.

• Brand Name: POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (8CM)
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5620045
• Report Number: 3006260740-2016-00200
• Device Sequence Number: 10777325
• Product Code: FOZ
• UDI-Device Identifier: 00801741038068
• UDI-Public: (01)00801741038068(17)161128(10)REZL0991
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2016
• Device Catalogue Number: M120081
• Device Lot Number: REZL0991
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1