MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP PORT ACCESS KIT 20G X 0.75IN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number PA-0031

Device Problem Activation Problem (4042)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/21/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported by the customer, i just want to make you aware that we use the safe step huber needle set port access kit in our infusion clinic.Unfortunately, one of our nurses rn, had a needle stick injury.She de-accessed a patient's port, the safety feature did not engage and when patient let go from holding his neckline, rn got stuck on her middle finger.No patient harm.However, i had to recall the patient to come back to have labs drawn since he already left when i found out about the incident.No other information was provided.

• Brand Name: SAFESTEP PORT ACCESS KIT 20G X 0.75IN
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16706917
• MDR Text Key: 312947436
• Report Number: 3006260740-2023-01244
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741085529
• UDI-Public: (01)00801741085529
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171735
• 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: 03/30/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: PA-0031
• Device Lot Number: REGX1822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White