MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 19G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of aseps0010 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via medwatch "when deaccessing a port-a-cath, the port needle did not retract into the safety. The needle had to be physically pulled out of the port and the safety was not able to be applied. " placement info: port a cath single lumen-right internal jugular no harm to patient.

• Brand Name: SAFESTEP HUBER NEEDLE SET 19G 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 10714389
• MDR Text Key: 213920411
• Report Number: 3006260740-2020-20208
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: LH-0033
• Device Lot Number: ASEPS0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/21/2020 Patient Sequence Number: 1