MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/17/2024
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
Material # f322088pt batch # rejs3882.It was reported the clinician attempted placement for a normal procedure, visualized both needle and catheter tip in vessel lumen, guide wire advanced smoothly but catheter and winds had difficulty advancing.Could not retract catheter back, catheter became stuck in skin, scalpel needed to knick skin to remove catheter.No patient damage reported.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 difficulty advancing the catheter was confirmed, but the root cause could not be determined.The product returned for evaluation was one 22g powerglide pro device.A gross visual inspection of the returned unit found that the catheter was broken into two pieces near the nose of the catheter hub.Microscopic inspection of the break site found that the break had a v-shape, likely indicating that the break originated as a tear from the needle piercing through the catheter tubing.Surrounding the break were several tear sites which had evidence of sharp instrument damage or needle spear through damage.Throughout the tubing were multiple areas of material buckling, suggesting that the catheter was inserted against resistance.Inspection of the catheter tip found buckling and deformation of the tip edge, further suggesting that the catheter was inserted against resistance.The guidewire was removed from the needle for inspection.Inspection of the guidewire found that guidewire had a break.The broken off piece of the guidewire was unable to be located and appeared to not have been returned.The fracture surface of the guidewire was granular and a profile view of the fracture surface identified the presence of material necking.Both features indicative of tensile failure which may have been caused by a strong pull on the wire.The event description suggests that heavy manipulation was necessary to remove the catheter from the patient.Therefore, it is unknown if the damage observed within the first 2cm of the catheter tubing was caused by the manipulation performed by the clinician during catheter removal.The other features observed indicate that the catheter was inserted against resistance.However, the features do not provide enough evidence to conclusively determine a root cause.Therefore, the root cause remains unknown.

• Brand Name: FULL KIT 22G X 8 CM WITH BIOPATCH 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: 20683624
• Report Number: 3006260740-2024-06651
• Device Sequence Number: 7281494
• Product Code: FOZ
• UDI-Device Identifier: 00801741140693
• UDI-Public: (01)00801741140693(11)240731(17)250731(10)REJS3882
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/21/2025

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F322088PT
• Device Lot Number: REJS3882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: Required Intervention
• Patient Sex: Unknown