MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH; MIDLINE CATHETER

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

The information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redq0747 showed no other similar product complaint(s) from this lot number.- attachment: [mw5092755 (b)(4)].

Event Description

It was reported via medwatch "when vat nurse inserting the transducer it would not advance.Ended up having to use another one because of it not advancing.When it was pulled out, we noticed the tip had three round rings on it.It looks like the product when manufactured was caught up so, it made it have the rings.".

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH
• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 9878945
• MDR Text Key: 186694561
• Report Number: 3006260740-2020-01018
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741153983
• UDI-Public: (01)00801741153983
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2020,03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: S4153108BD
• Device Lot Number: REDQ0747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2020
• Distributor Facility Aware Date: 01/23/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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
• Patient Age: 64 YR
• Patient Weight: 68