MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWERGLIDE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

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, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint that the dilator was not removed from the powerglide catheter appeared to be associated with use.Two photographs were provided for investigation.One photo showed the powerglide catheter with the dilator connected to the catheter.The guidewire was also shown in its hoop.One photo showed a portion of the instructions for use (ifu).The ifu states, ¿remove the dilator and guidewire, leaving the catheter positioned in the vasculature.Caution: leaving dilator in catheter could result in patient discomfort and reduced catheter performance (e.G.Occlusion, aspiration, and infusion).¿ it was reported that fluid could not be injected or aspirated, and it was observed that the dilator had been left inside the catheter.The reported event appeared to be associated with use of the device.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 via ms&s " that during the covid-19 pandemic they brought in contract anesthesiologists to assist.One of the anesthesiologist placed a powerglide midline.When the nurses attempted to use it they could not inject or draw blood.The line was removed and the nurse noted that the dilator had been left inside the midline occluding the lumen.He does not have the product or lot number today but emailed me a photo with an arrow at the dilator that was left in place.He stated that the patient suffered no ill effects and the patient had several other usable intravenous lines which were able to be used.".

• Brand Name: BARD POWERGLIDE
• 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: 10371118
• MDR Text Key: 202214559
• Report Number: 3006260740-2020-02789
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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