MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that 3 patients have had leaking at the insertion site of clear or slightly blood tinged fluid.This has occurred with patients receiving antibiotics via a 24 hour baxter infuser as well as intermittent iv antibiotics.There was no reported patient injury.This report addresses the first patient.

Manufacturer Narrative

H11:section a through f - 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 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 midline catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 4fr s/l powermidline midline catheter.Usage residues were exhibited throughout the sample.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (15 seconds) hydraulic pressurization of the device.Microscopic inspection of the sample did not reveal any evidence of leakage.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that 3 patients have had leaking at the insertion site of clear or slightly blood tinged fluid.This has occurred with patients receiving antibiotics via a 24 hour baxter infuser as well as intermittent iv antibiotics.There was no reported patient injury.This report addresses the first patient.

• Brand Name: BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9494870
• MDR Text Key: 176447121
• Report Number: 3006260740-2019-03923
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741141034
• UDI-Public: (01)00801741141034
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P6154118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1