MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP PORT ACCESS KIT 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Anxiety (2328); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that when accessing the port and drawing back blood upon access and then pulsatile flush back and get saline mixed with the blood coming from the hub, leaked forcefully, and it came out forcefully and hit the patient in the neck.It was stated there was no injury but the device leaked on the patient and the nurse.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that when accessing the port and drawing back blood upon access and then pulsatile flush back and get saline mixed with the blood coming from the hub, leaked forcefully, and in once instance it came out forcefully and hit the patient in the neck.No injury, but leaked on the patient once and on nursing.Additional information received: the event did not involve an urgent or life threatening medical situation.The leak was discovered after port was accessed.Leak not noticed while checking for blood return but was noticed while forward flushing with a 10cc normal saline syringe.The leak was also not discovered during the initial priming of the tubing prior to access.Normal saline was infusing at the time of the event.There was no interruption or delay in the administration of medication that negatively impacted the patient.Patient experienced situational anxiety as she does not like her port being accessed and had to experience 2 port accesses in this case as the first needle was unable to be used.She understood that a de-access of this needle and another port access with a new needle had to be done but was not happy with this.
Additional 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.

• Brand Name: SAFESTEP PORT ACCESS KIT 20G X 1 IN
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16565293
• Report Number: 3006260740-2023-00880
• Device Sequence Number: 5423390
• Product Code: FPA
• UDI-Device Identifier: 00801741085543
• UDI-Public: (01)00801741085543
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: PA-0032
• Device Lot Number: REGW2602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: Black Or African American