MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SHERLOCK 3CG PLUS TCS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the p-wave technology was not consistently capturing their peaked p-waves accurately, causing them to leave too much external length or advancing too far in with catheter on the small tablet.Said technology was inconsistent confirming placement, as sometimes it would work properly.But due to their lack of confidence in the technology, they still ordered cxr to confirm tip placement.
Additional Manufacturer Narrative
The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
It was reported by the customer that the p-wave technology was not consistently capturing their peaked p-waves accurately, causing them to leave too much external length or advancing too far in with catheter on the small tablet.Said technology was inconsistent confirming placement, as sometimes it would work properly.But due to their lack of confidence in the technology, they still ordered cxr to confirm tip placement.It was reported by bd clinical specialist ¿i went to the account today to observe their set up and picc insertion on pediatric patient using the small sherlock 3cg technology.The technology did in fact fail to function properly, despite it being used correctly.Picc was placed bedside.On the insertion, as the catheter was threaded into the svc, it began showing biphasic p-waves that minimized in deflections as the picc continued to thread towards the caj.Once the picc was at the measured length, it reflected maximum peaked p-waves with no deflection.I had the inserter push the catheter in farther towards the hub, and the p-waves became smaller with no deflections.As we pulled back on the catheter beyond measured length, it began to show deflections.It was as if the technology was reading the interpretation backwards.I had the inserter leave the picc at the measured length with the peaked p-waves and order a chest x-ray, which confirmed picc tip placement in perfect position at svc/caj.I could not troubleshoot through this technical issue as the technology was set up perfect externally with the leads and positioning of the sherlock.On a few occasions we did lose the rhythms (internal and external) on the screen, checked connections which appeared all intact, ¿jiggled¿ the sherlock a little, and then the came back.Patient did not present with any cardiac abnormalities; she was in normal sinus rhythm.They deny dropping the sherlock anytime or knowing of it being ¿damaged¿.

• Brand Name: SHERLOCK 3CG PLUS TCS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16501690
• Report Number: 3006260740-2023-00718
• Device Sequence Number: 3354114
• Product Code: LJS
• UDI-Device Identifier: 00801741163029
• UDI-Public: (01)00801741163029
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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 Model Number: N/A
• Device Catalogue Number: 9770351
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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