MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported by the customer "nurse set up and accessed the vein.Clearly in center of vein and realized the device was upside down.Picked up probe and flipped it back over and saw it was still in the center of the vein, deployed the guidewire smooth as butter, took the wings forward and got halfly down, it stopped but bumped it and it would not go all the way and pulled out whole the device back.Trey dropped a new needle and when looking at the same vein to reinsert a new catheter realized that there was something in the vein.Stopped procedure.Pulled the catheter apart and realized the tip was missing.Patient had to have 2cm of tip surgically removed." no other information was provided.
Event or Problem Description
It was reported by the customer "nurse set up and accessed the vein.Clearly in center of vein and realized the device was upside down.Picked up probe and flipped it back over and saw it was still in the center of the vein, deployed the guidewire smooth as butter, took the wings forward and got halfly down, it stopped but bumped it and it would not go all the way and pulled out whole the device back.Trey dropped a new needle and when looking at the same vein to reinsert a new catheter realized that there was something in the vein.Stopped procedure.Pulled the catheter apart and realized the tip was missing.Patient had to have 2cm of tip surgically removed." no other information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a break in the catheter is confirmed and was determined to be use-related.One 20 ga powerglide pro was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned powerglide pro.The catheter was returned detached from the needle and attached to the pink, plastic slider.The guidewire was observed to be sticking out from the safety mechanism.A microscopic observation revealed the distal tip of the catheter was missing.The break in the catheter was circumferentially aligned and exhibited a chevron-shaped break with a granular fracture surface.Because of the observed characteristics of the break site in the catheter and the advancement into the tissue of the patient described in the event description, the complaint of a broken catheter is confirmed and was determined to be use related and appeared to be caused by contact between the catheter and the needle tip.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.

• Brand Name: FULL KIT 20G X 8 CM WITH 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19119013
• Report Number: 3006260740-2024-01801
• Device Sequence Number: 8359328
• Product Code: FOZ
• UDI-Device Identifier: 00801741140624
• UDI-Public: (01)00801741140624
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F220088PT
• Device Lot Number: REHX1118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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