MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 8CM BASIC KIT; INTRAVASCULAR CATHETER

Model Number	F120080
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	07/09/2017
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 for evaluation.A lot history review (lhr) of rebq2563 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per medwatch report, the facility reported that 1 cm portion of midline catheter sheared off after encountering resistance during placement.It was stated the patient required minor surgery under local anesthesia to remove retained catheter portion.

• Brand Name: PG PRO 20G 8CM BASIC KIT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6869239
• Report Number: 3006260740-2017-01634
• Device Sequence Number: 659703
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/15/2017
• Report Date (Section F): 07/19/2017

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 Model Number: F120080
• Device Catalogue Number: F120080
• Device Lot Number: REBQ2563
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2017
• 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
• Date Report Sent to FDA: 07/19/2017