MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH BIOPATCH 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	05/22/2024
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.
Event or Problem Description
It was reported via medwatch, an attempt was made to place an 18g powerglide midline to the patient¿s right cephalic.Adhering to sterile technique, the 18g catheter was guided into the center of the right cephalic vein using ultrasound guidance.The guidewire was advanced but was unable to advance the catheter without resistance.The catheter was retracted, then the guidewire.When the cannula was rendered safe by locking the needle, it appeared to be missing 1cm of the catheter tip.Ultrasound revealed what appeared to be the catheter tip in or near the cephalic vein.Physician was immediately notified, and a rue ultrasound was ordered.Vascular access rn was also notified.Patient reported no pain or discomfort at the insertion site.No other information was provided.

• Brand Name: FULL KIT 18G X 10 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19787346
• Report Number: 3006260740-2024-03902
• Device Sequence Number: 8429159
• Product Code: FOZ
• UDI-Device Identifier: 00801741140662
• UDI-Public: (01)00801741140662
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: F318108PT
• Device Lot Number: REHW2056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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 Age: 57 YR
• Patient Sex: Male