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/Blood Leak (1250)

Patient Problem Pain (1994)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 20ga x 1¿ powerloc max safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.A needleless injection cap was attached to the luer adapter.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) hydraulic pressurization.Microscopic inspection of the sample did not reveal any evidence of current or prior leakage.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.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 "rn account: pt had ns running at 120ml/hr and blinatumomab at 5ml/hr.Pt called rn in notifying of pts port leaking.Rn checked all connections and port was leaking under the dressing (dressing was intact with steri strips on site and line guard in tact).Iv fluid and blinatumomab paused and tried to pull back, unable to get blood return attempted to flush small amount and fluid leaking under port site.Port deceased and had 1 inch needle in.Site seemed tight and slightly swollen.Notified pharm d and doc (who evaluated the site prior to reaccessing).Port reaccessed with a 1.5 inch needle with good blood return." add info rcvd 03/23/2021: what type of catheter securement was utilized: centurion lineguard was there patient harm reported?: just the pain from re-accessing site.

• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11680397
• MDR Text Key: 245848531
• Report Number: 3006260740-2021-01383
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047466
• UDI-Public: (01)00801741047466
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• 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: 0142075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2021
• 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