MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4FR DL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER

Model Number N/A

Device Problem Activation Problem (4042)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of reen3365 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reen3365) have been reported from the same facility.

Event Description

It was reported that after placing the double lumen midline, while picking up and disposing of the introducer needle into the sharps bin the rn obtained a contaminated needle stick.The safety mechanism did not fully engage.

• Brand Name: 4FR DL PROVENA MIDLINE MAX BARRIER KIT
• 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: 10217543
• MDR Text Key: 197142069
• Report Number: 3006260740-2020-02299
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154119
• UDI-Public: (01)00801741154119
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: S4254108D
• Device Lot Number: REEN3365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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