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

Model Number N/A

Device Problems Defective Component (2292); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.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 "she stated she was placing a powerglide but did not save product.It was 20 gauge not sure length and did not have lot numbers.She said it sounded like a piece of plastic broke so the needle was not locked into the white portion so it was flimsy.The white clip on inside in the first clip broke they think is what broke." additional information received 07/19/2021: "the issue was with the needle guide half loop at the end of the power glide device, it was not holding the needle in place and that made the needle very unstable and the device wanted to split (as it should if you deployed or engaged) the catheter into the vessel.

Event Description

It was reported "she stated she was placing a powerglide but did not save product.It was 20 gauge not sure length and did not have lot numbers.She said it sounded like a piece of plastic broke so the needle was not locked into the white portion so it was flimsy.She showed me with a sample today and pictures are below.The white clip on inside in the first clip broke they think is what broke.The lower picture shows how needle is out of white portion." additional information received 07/19/2021 "the issue was with the needle guide half loop at the end of the power glide device, it was not holding the needle in place and that made the needle very unstable and the device wanted to split (as it should if you deployed or engaged) the catheter into the vessel.

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, 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 that the needle moved within the deployment system was confirmed, but the exact cause could not be determined from the two photographs were provided for investigation.The photos showed the powerglide attached to the deployment system.One photo showed what appeared to be the catheter over the needle shaft.The device was not in focus.The needle shaft was deflected from the normal path through the distal end of the deployment system.Due to the position of the needle, the deflection from the deployment system most likely occurred after the needle guard was removed; however, the observations of the photos did not point to a specific root cause.H3 other text : evaluation findings are in section h.11.

• Brand Name: BARD POWERGLIDE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12214448
• MDR Text Key: 263103936
• Report Number: 3006260740-2021-02908
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

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 Model Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/24/2021
• 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
• Patient Outcome(s): Other