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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
Bd representative provided the following information: "notified this morning by the account that a powerglide catheter broke off in a patients arm.At this time i am awaiting for the picc nurse to call me to describe the event.This nurse was the placer of the device.Was provided a small bit of information from the nurse as she stated that at this time the catheter is still in the patients arm and the patient is refusing removal.An x-ray was confirmed that there was a foreign body in the left cephalic vein.Based of the remaining catheter that was removed from the patient, it appears that about 1.3cm is remaining in the patients upper extremity." additional information received 3/8/2023: the clinician provided the following details to the bd representative: rn reported that she assessed the l.Cephalic vein and a 20g was suitable for the placement.Reported vessel was compressible and about 1cm deep.Stated when she launched the guidewire the wire went in smoothly and then advanced her catheter which went smoothly up until about halfway when she met slight resistance.Reported stopping the procedure due to the resistance and pulled the wire back and then the device without difficulty.Stated that after she removed the device she noticed the catheter looking shorter and that the purple reinforced tip was not at the top of the catheter.At that time she assessed the site and stated the patient reported zero pain.X-ray was then ordered that confirmed foreign body in the l.Cephalic vein.Patient refused removal of foreign body.Unknown at this time of the patient status.

• Brand Name: FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER
• Common Device Name: 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16592943
• Report Number: 3006260740-2023-00963
• Device Sequence Number: 17474257
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: F120108PT
• Device Lot Number: REGX0602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown