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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 4fr d/l powermidline midline catheter.Usage residues were observed throughout the sample.Microscopic inspection of the sample did not reveal any evidence of damage or prior leakage.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (greater than 15 seconds) hydraulic pressurization of the sample.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.A lot history review (lhr) of redx2343 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported ¿appeared to be leaking from catheter¿.No other information was provided.

• 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: 9985591
• MDR Text Key: 196234211
• Report Number: 3006260740-2020-01476
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: S4254108D
• Device Lot Number: REDX2343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/22/2020
• 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