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

Catalog Number	F120107T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2024
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that after the powerglide was placed and the clinician flushed the line, she noticed that there was leaking where the catheter and hub meet.She pulled it out a bit and flushed again and confirmed that there was a shear in the catheter.There was no patient harm.Clinician had to pull out the powerglide and place another.No other information provided, at this time.
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 split in the catheter shaft is confirmed and was determined to be use-related.One 20 ga accucath ace catheter was returned for evaluation.An initial visual observation of the returned sample revealed some light saline use residues throughout the returned device.The returned catheter was observed to have a sharp kink at the luer/catheter junction.A microscopic observation revealed a split in the catheter just distal of the luer of the device.The split was observed to have sharp fracture edges and a shiny fracture surface.The split appeared to be primarily longitudinal with some flared sections in the circumferential direction toward the proximal end of the catheter.The catheter had characteristics of a split caused by a sharp instrument such as a needle bevel.Pulling the catheter back against the needle bevel may cause splits along the catheter shaft.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer that after the powerglide was placed and the clinician flushed the line, she noticed that there was leaking where the catheter and hub meet.She pulled it out a bit and flushed again and confirmed that there was a shear in the catheter.There was no patient harm.Clinician had to pull out the powerglide and place another.No other information provided, at this time.

• Brand Name: BASIC KIT 20G X 10 CM WITH GUARDIVA
• 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20540098
• Report Number: 3006260740-2024-06215
• Device Sequence Number: 6641938
• Product Code: FOZ
• UDI-Device Identifier: 00801741140488
• UDI-Public: (01)00801741140488(11)240816(17)250831(10)REJU0283
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/24/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: F120107T
• Device Lot Number: REJU0283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: Other
• Patient Sex: Unknown