MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SHERLOCK 3CG; CENTRAL VENOUS CATHETER NAVIGATION SYSTEM, ELECTROCARDIOGRAPHIC/MAGNETIC

Catalog Number	9770351
Medical Device Problem Codes	No Apparent Adverse Event (3189); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 the vascular access team have had intermittent occurrences of confirming piccs using ecg, & finding the catheters placed too deep on subsequent x-rays.It is possible this issue is with the sherlock equipment.
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.Product was not returned for evaluation/repair.Photo samples provided were reviewed by radiologist.In the first image provided, tip of the picc was found to be overlying the right atrium.Second radiograph image appears to be post-retraction of the picc compared with the first image and the tip appears to be overlying the distal svc.Radiologist indicates picc tip is too far/low.Full evaluation by radiologist is attached to attachments file.Complaint investigation and root cause determination could not be completed without physical evaluation of the unit.

• Brand Name: SHERLOCK 3CG
• Common Device Name: CENTRAL VENOUS CATHETER NAVIGATION SYSTEM, ELECTROCARDIOGRAPHIC/MAGNETIC
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23771988
• Report Number: 3006260740-2025-09524
• Device Sequence Number: 18782098
• Product Code: LJS
• UDI-Device Identifier: 00801741163029
• UDI-Public: (01)00801741163029(11)230401
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180560
• 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): 04/15/2026

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 Catalogue Number: 9770351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown