MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

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 that patient who went home with her 5 fu chemo pump infusing via huber needle/port.It was stated the patient had chemo leaking from the secondary port.There is sediment around the secondary port.Additional information received 09/09/2021: date of occurrence: (b)(6) 2021.Placement date: huber inserted (b)(6) 2021.Explant date: huber needle removed (b)(6) 2021.Placement info: safestep 20 gauge, 3/4 inch huber.What type of catheter securement was utilized: chg patch, steri strips, tegaderm was there patient harm reported?: skin slightly reddened "sunburn like".What they¿re being treated for: pancreatic adenocarcinoma.

Event Description

It was reported that patient who went home with her 5 fu chemo pump infusing via huber needle/port.It was stated the patient had chemo leaking from the secondary port.There is sediment around the secondary port.Additional information received 09/09/2021: date of occurrence: (b)(6), 2021 placement date: huber inserted (b)(6), 2021 explant date: huber needle removed (b)(6), 2021 placement info: safestep 20 gauge, 3/4 inch huber what type of catheter securement was utilized: chg patch, steri strips, tegaderm was there patient harm reported?: skin slightly reddened "sunburn like" what they¿re being treated for: pancreatic adenocarcinoma.

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), labeling, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak at the y-site of the returned 20g x ¾¿ safestep with y-site was confirmed.A white powdery substance was seen around the perimeter of the blue valve stem and within the threads of the y-site housing on the returned sample.Under microscopic examination, the entire perimeter of the valve stem contacted the valve housing.Functional testing of the infusion set revealed that the infusion set was patent to infusion and aspiration.No occlusions were detected in the device.When the infusion set was flushed through the proximal connector, no leaks were seen along the valve or the valve housing.Initially, upon pressurizing the lumen, no leaks were observed.However, pressurizing the lumen through the proximal connector, after the y-injection site was accessed with the syringe and flushed with water, caused small drops of fluid to become visible at the y-site along the edge of the blue valve stem.No continuous leak of fluid was observed when the infusion set was under a positive pressure and no leak of air was aspirated through the valve when the infusion set was under a negative pressure.The blue stem of the valve moved slightly according to the pressure to which it was exposed.Under vacuum, the exposed surface of the stem was slightly drawn within the white valve housing.A positive pressure caused the top of the stem to extend slightly from the white valve housing.Any fluid that was positioned between the blue valve stem and the white valve housing appeared to be pushed out from the white valve housing under a positive pressure.The product ifu warns, ¿needleless y-injection site valve may leak slightly at certain pressures resulting in a small bead of fluid on the valve.¿ h3 other text : evaluation findings are in section h.11.

• Brand Name: HUBER NEEDLE
• 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12529627
• MDR Text Key: 273351905
• Report Number: 3006260740-2021-03989
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/19/2021
• 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