MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE 19GX0.75"; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0033

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of aseps0043 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported via medwatch "when removing the port needle, safety did not work.Needle exposed to nurse and patient, no injury." occurred when deaccessing port.No other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE 19GX0.75"
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 10901103
• MDR Text Key: 218931500
• Report Number: 3006260740-2020-20654
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066245
• UDI-Public: (01)00801741066245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LH-0033
• Device Catalogue Number: LH-0033
• Device Lot Number: ASEPS0043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2020
• 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): Other