MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3FR SL PROVENA MIDLINE MAX BARRIER KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problems Erythema (1840); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recs2083 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via ms&s that patient reports that she had a provena midline placed (b)(6)2019 for antibiotic therapy.She was admitted to a skilled nursing facility on (b)(6) 2019 and they did the dressing changes on (b)(6) 2019, she saw her surgeon and he asked his nurse to remove the midline.She reports that when the nurse removed the dressing the "device fell apart".The patient reports that she can see and feel the white cannula in the vein at the insertion site.The surgeon told her to go to the er where the device was placed.She reports redness and pain at the insertion site around the white plastic catheter.Response to patient: confirmed that she needs to see an md or healthcare provider who can explore the insertion site and remove the catheter if it is still inside the vein.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: 8524696
• MDR Text Key: 142325611
• Report Number: 3006260740-2019-00905
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S4153108D
• Device Lot Number: RECS2083
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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 Outcome(s): Hospitalization; Other; Required Intervention