MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER MAXIMAL BARRIER TRAY; INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2017
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 for evaluation.A lot history review (lhr) of rebn1664 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (rebn1664) have been reported from the same facility.
Event or Problem Description
It was reported by the facility that the clamp broke on the end of the slide.It was stated the facility used chg to clean the catheter but not the clamp.Facility contact reported that the dressing is changed every six days with use of chg and the catheter is accessed for infusion and aspiration every eight hours or with intermittent use.The clamp broke after a few days of use.This report address the second clamp.

• Brand Name: POWERGLIDE MIDLINE CATHETER MAXIMAL BARRIER TRAY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7089378
• Report Number: 3006260740-2017-02201
• Device Sequence Number: 16426847
• Product Code: FOZ
• UDI-Device Identifier: 00801741038136
• UDI-Public: (01)00801741038136
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K133856
• 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): 12/06/2017

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: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: M118101D
• Device Lot Number: REBN1664
• 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: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1