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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Urticaria (2278)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3006260740-2022-05615
• Device Sequence Number: 20415565
• Product Code: FPA
• UDI-Device Identifier: 00801741044410
• UDI-Public: (01)00801741044410
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown