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	Foreign Body In Patient (2687)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that he noticed bleeding immediately and pulled back on the entire device.He saw the lights from the needle shining in the ultrasound picture.When he withdrew the device, 2 cms of the catheter were left in the patient.The patient had to go to surgery to remove.Device was inserted into the patient's right cephalic and hit a wall.
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.
Event or Problem Description
It was reported by the customer that he noticed bleeding immediately and pulled back on the entire device.He saw the lights from the needle shining in the ultrasound picture.When he withdrew the device, 2 cms of the catheter were left in the patient.The patient had to go to surgery to remove.Device was inserted into the patient's right cephalic and hit a wall.
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 attached to the needle and attached to the pink, plastic slider.The safety mechanism was not advanced over the needle tip.The needle was observed to be bent.The returned catheter was observed to be broken with the distal fragment of catheter detached from the needle.A microscopic observation revealed 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18379526
• Report Number: 3006260740-2023-05803
• Device Sequence Number: 7767384
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F220088PT
• Device Lot Number: REHV1191
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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