MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 10 CM WITH GAURDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reer3463 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "inserted midline.Encountered some difficulty in threading cath completely in, but trouble shooting with the 10cc ns flush allowed good blood flow and eventually threaded completely in (also with good blood flow and flushing at that point).As device was removed from skin, noted that only 1/3" of the guide wire was exposed on the end of device (normally 1" is exposed).Radiology work area informed and humerus x-ray ordered.Resident ordered chest x-ray.Ct chest-neg for fb".

• Brand Name: BASIC KIT 20G X 10 CM WITH GAURDIVA
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12214424
• MDR Text Key: 263102755
• Report Number: 3006260740-2021-02907
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140488
• UDI-Public: (01)00801741140488
• 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,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120107T
• Device Lot Number: REER3463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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): Required Intervention