MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 0724086

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

When deceasing the bard power loc max port needle from the patient's port the needle safety would not engage.It had to be removed without the safety.This risks staff and patient to needle contamination poke.We continue to have frequent events with this product.It is in for a short time in clinic.Sometimes you can see a slight bend to the needle reported in two previous events and the safety would not engage, sometimes you can not see any reason as was reported in three other instances.In total we have had 5 events with this product involving the engagement of the safety needle.No packaging has been saved so lot numbers have not been identified.Manufacturer response for port access, (brand not provided) (per site reporter).Manufacturer local rep has been notified each occurrence that has occurred.Product prior has been sent into their quality department pending investigation.Meeting with rep to discuss concerns with product.

• Brand Name: POWERLOC
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 6968373
• MDR Text Key: 89948673
• Report Number: 6968373
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 0724086
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO