MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX INFUSION SET 20G X .75 IN.; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Fever (1858); Viral Infection (2248)

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 via medwatch "my daughter has acute lymphoblastic leukemia.She is currently admitted to children's hospital due to fever and multiple viruses.My daughter woke up from her nap around 5pm in a pool of blood.I tore her clothes off to find thather port was broken were the clamp is supposed to close.The nurse had failed to clamp either clamps, leading my daughter to be exposed to bacterial for an undetermined amount of time (possibility of 4 hours).The brand of needle/line was powerloc max (.75 inch, 20 gauge needle) and had somehow formed a hole in it.This is not the first time this has happened.In fact.This is the 5th time, with 4 other breakages of the same type happening in 2018.Each time this happens, my daughter is exposed to harmful, life threatening bacteria." this report addresses the second of four events in 2018.

• Brand Name: POWERLOC MAX INFUSION SET 20G X .75 IN.
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8848969
• MDR Text Key: 153077616
• Report Number: 3006260740-2019-02245
• 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: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2019,07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2019
• Distributor Facility Aware Date: 06/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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