MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC PORT ACCESS KIT 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Urticaria (2278)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refy3700 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by patient¿s caretaker, the patient had a reaction to the needle in the port kit.Patient states she has a nickel allergy, asking if we make a non-corning needle that does not contain nickel.Caller states she was using the huber plus non-coring needle in the past and did not have any issues with this device.Caller describing hives, raised red areas, itching, puffiness near where her port is located.Response: explained that both the huber plus and miniloc port access needles are stainless steel and will contain some nickel.Bd does not manufacture a non-coring needle that does not contain nickel.Discussed other possibilities for a reaction including which dressing was used and skin prep like chlorhexidine.Also explained huber plus has been discontinued.Offered non-power option, safestep lh-0029 and power rated option, 0652234.Suggested she discuss this further with her doctor who should be able to help get additional supplies.

• Brand Name: MINILOC PORT ACCESS KIT 22G 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15934426
• MDR Text Key: 305012238
• Report Number: 3006260740-2022-05615
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741044410
• UDI-Public: (01)00801741044410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 2632234
• Device Lot Number: REFY3700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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