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

Model Number	M120080
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rebs2352 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the facility placed a powerglide into the patient's right forearm on (b)(6) 2017.On (b)(6) 2017, according to the patient, leaking was noted after flushing.When the midline was removed by the nurse, the 8 cm catheter was detached from the hub.It was reported this was witnessed by the patient.The patient is currently awaiting ct scan with possible interventional radiology removal of the catheter.

• Brand Name: POWERGLIDE MIDLINE CATHETER, 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: 6863656
• Report Number: 3006260740-2017-01586
• Device Sequence Number: 712453
• Product Code: FOZ
• UDI-Device Identifier: 00801741075315
• UDI-Public: (01)00801741075315
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: M120080
• Device Catalogue Number: M120080
• Device Lot Number: REBS2352
• 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: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention