MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PFLEX, 20G 8CM FULL (POWERGLIDE PRO); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F120081
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
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 rebr0658 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 had a powerglide pro midline catheter that was being removed from the patient and the catheter broke away from the hub.The catheter had to be surgically removed from the patient.

• Brand Name: DOT PFLEX, 20G 8CM FULL (POWERGLIDE PRO)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6799250
• Report Number: 3006260740-2017-01304
• Device Sequence Number: 1247815
• Product Code: FOZ
• UDI-Device Identifier: 00801741110573
• UDI-Public: (01)00801741110573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: 06/30/2018
• Device Model Number: F120081
• Device Catalogue Number: F120081
• Device Lot Number: REBR0658
• 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: 08/16/2017
• 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