MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Extravasation (1842); Swelling/ Edema (4577)

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.

Event Description

It was reported a patient who attended the removal of the infuser on (b)(6) 2023 finding extravasation of the content in soft tissues, a patient who in turn initially on day 1 of his chemotherapy (b)(6) 2023 was accessed with a 20*19 huber needle which dislodged during the infusion at the patient's home, needle has not met safety to enable the catheter.Extravasation of cytotoxic chemotherapy.On (b)(6) 2023 during a meeting it was reported: patient arrived at the facility with erythema and induration.The drug administered was fluorouracil.However, it's needed to talk to the nurse to understand what happened to the needle.There are no pictures and the needle has been discarded.Additional information received on (b)(6) 2023: customer reported that extravasation is evidenced by notable edema in the chest region prior to nursing assessment of the area of the implantable catheter.The content that was extravasated was 5-fluorouracil.The needle was displaced from the insertion site.The port needle was withdrawn.The patient complained of pain and referred to the emergency room.A chest ultrasound was taken on (b)(6) 2023 and showed "an increase in the thickness of the skin and subcutaneous tissue that reached a depth of 7 mm.Laminar fluid that dissects the subcutaneous fat planes in the left pectoral and cervical region, with no evidence of collections." the patient received antibiotic treatment with clindamycin.

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.

Event Description

It was reported a patient who attended the removal of the infuser on (b)(6) 2023 finding extravasation of the content in soft tissues, a patient who in turn initially on day 1 of his chemotherapy (b)(6) 2023 was accessed with a 20*19 huber needle which dislodged during the infusion at the patient's home, needle has not met safety to enable the catheter.Extravasation of cytotoxic chemotherapy.On 17/mar/2023 during a meeting it was reported: patient arrived at the facility with erythema and induration.The drug administered was fluorouracil.However, it's needed to talk to the nurse to understand what happened to the needle.There are no pictures and the needle has been discarded.Additional information received on 17/mar/2023: customer reported that extravasation is evidenced by notable edema in the chest region prior to nursing assessment of the area of the implantable catheter.The content that was extravasated was 5-fluorolacil.The needle was displaced from the insertion site.The port needle was withdrawn.The patient complained of pain and referred to the emergency room.A chest ultrasound was taken on (b)(6) 2023 and showed "an increase in the thickness of the skin and subcutaneous tissue that reached a depth of 7 mm.Laminar fluid that dissects the subcutaneous fat planes in the left pectoral and cervical region, with no evidence of collections." the patient received antibiotic treatment with clindamycin.Additional information received april 28, 2023: during the patient care process, no port quality deviation was identified.There was no rupture of the needle, it did not come off the hub, it refers to the fact that the needle was not positioned in the membrane of the implantable port at the time of the revision.It was confirmed that there was a chemotherapy leak due to the signs of erythema that the patient presented, pain, burning, and radiological images performed; taking into account that the needle has moved, it is improbable to affirm that the leak occurred through the bevel of the needle.

• Brand Name: SAFESTEP HUBER NEEDLE 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16632534
• MDR Text Key: 312194487
• Report Number: 3006260740-2023-01041
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: LH-0031
• Device Lot Number: ASGRFC119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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): Required Intervention