MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid Leak (1250)

Patient Problem Erythema (1840)

Event Date 05/01/2021

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 "the patient had a port placed in the or on 4/30. On 5/1 after the third dose of mesna, the patient's dad noticed that there was blood on the patient's hospital gown. Upon looking at the port dressing, there was blood and fluid within the port dressing as if the port was leaking. Rn flushed the port and got great blood return when assessing the port dressing (i checked this patient's port for blood return with labs at 0900, one other time between 1000-1300 because the mivf running alarmed "line occluded", and again when assessing this port leakage situation). When flushing the port, it looked like some ns was leaking into the dressing. I stopped the mivf that was running and asked for help. We thought maybe the port needle tubing was broken so we de-accessed and re-accessed the patient. The patient's port site looked fine, no sign of infiltration or bogginess, it was just a little bit red around the port needle site. It was noted that the patient's port was not steri-stripped down so when the patient was re-accessed we made sure to use steri-strips. " "we saved the port needle tubing but could not find a breakage in the tubing. It seems that when it is flushed, the fluid only comes out of the port needle and is not leaking anywhere else throughout the tubing. ".

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12182113
• MDR Text Key: 262023256
• Report Number: 3006260740-2021-02786
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 0142075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/22/2021
• 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 Treatment Data

Date Received: 07/16/2021 Patient Sequence Number: 1