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

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redz1548 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redz1548) have been reported from the same facility.

Event Description

It was reported: "a virtual demonstration of provena picc kits was provided to vascular access nurses at hospital.Samples of 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 second kit.

• Brand Name: 4FR DL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 10378384
• MDR Text Key: 202015341
• Report Number: 3006260740-2020-02841
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154164
• UDI-Public: (01)00801741154164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: S4254108BDP
• Device Lot Number: REDZ1548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1