MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4FR DL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reer0574 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (reer0574) have been reported from the same facility.
Event or Problem Description
On (b)(6) 2020 "a virtual demonstration of provena picc kits was provided to vascular access nurses at hospital.Samples of a 4fr provena picc kit were provided.During discussion nurses and bd cs noticed that pieces of gt needle guide plastic fragmented off as insertion needle was inserted into each of the needle guides.Several nurses attempted using the gt needle guides with the same result of plastic shearing off the center of the needle guide.This is a potential patient care complication because the plastic could become an emboli in the patients blood stream." this occurred with three kits.This report addresses the first kit.

• Brand Name: 4FR DL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10376767
• Report Number: 3006260740-2020-02820
• Device Sequence Number: 2686945
• Product Code: PND
• UDI-Device Identifier: 00801741154164
• UDI-Public: (01)00801741154164
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: S4254108BDP
• Device Lot Number: REER0574
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1