MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROVENA TM MIDLINE CATHETER 3F SL

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged introducer was confirmed, but the exact cause could not be discerned from the two photographs that were provided for investigation.Both photos showed what appeared to be a microintroducer.The edge at the distal end of the sheath exhibits deformation and the distal end of the sheath tubing was buckled in multiple locations.What appeared to be blood residue was observed throughout the sample.The dilator remained attached to the sheath.A bend was observed in the dilator and overlying sheath.One photo showed the label with part number ck000917 and lot #redx5156.The introducer in the photo matched the characteristics of the 3.5fr x 7cm microintroducer that is contained in the implicated kit.This type of damage can occur during use when the sheath comes in contact with the surrounding tissue of the insertion site.The sheath and dilator should be advanced together as a unit over the guidewire, using a slight rotational motion.Since the damage was observed on the sheath, the complaint was confirmed.A lot history review (lhr) of redx5156 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "dilator peel apart sheath, issues continue, i was able to salvage this 3 fr.Midline iv dilatator, unable to use this dilator despite skin nick.I avoid skin nicking." additional information received: 03/04/2020 - attempting to advance dilator and sheath over wire, device would not penetrate skin, buckled after making skin nick continued difficulty advancing after 3rd attempt to advance sheath became accordion like.

• Brand Name: PROVENA TM MIDLINE CATHETER 3F SL
• 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: 9876077
• MDR Text Key: 194017715
• Report Number: 3006260740-2020-00982
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741187827
• UDI-Public: (01)00801741187827
• 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
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• 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: CK000917
• Device Lot Number: REDX5156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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: 76 YR