MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

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.A lot history review (lhr) of refs0821 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (refs0821) have been reported from the same facility.Device not returned for evaluation.

Event Description

It was reported "the picc nurse had 5 of these lines double back on her in a course of 2 days." additional information received "from what i gathered, the lines would create a u upon insertion or coil during placement.Secondly, there was no patient harm." (b)(6) 2022 -one used sample was returned to represent the 5 affected units.The returned sample showed kink damage.The facility reported the same issue occurring on 5 catheters.This report addresses the fifth device/no sample returned.

• Brand Name: FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13536389
• MDR Text Key: 285684961
• Report Number: 3006260740-2022-00324
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140563
• UDI-Public: (01)00801741140563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F118108PT
• Device Lot Number: REFS0821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• 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